The FDA Group - Podcast Details

Shows

FDA Watch How Industry Is Adapting to FDA's Food Shifts Wayne chats with Sarah Sorscher, Director of Regulatory Affairs at the Center for Science in the Public Interest, and Sarah Gallo, Senior Vice President of Product Policy and Federal Affairs at the Consumer Brands Association. You'll hear their thoughts on the current state of foods at FDA, concerns related to the agency's budget, impacts of the government shutdown on FDA and the Human Foods program, how federal regulation might affect state regulation, changes to the GRAS process and post-market review, how industry is adapting to evolving guidance on ultraprocessed foods, and much more. Read Sarah Sorscher's statement...

2025-11-1749 min

Citeline Podcasts Drug Fix: Examining George Tidmarsh’s Departure As Head Of US FDA’s Drug CenterPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs take a deep dive into the circumstances of George Tidmarsh’s departure as director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (:30). They also consider the long-term impact on the agency (11:50) and try to place it in context compared to other crises in its history (31:24). More On These Topics From The Pink Sheet Breaking: George Tidmarsh Out As US FDA Drug Center Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-george-tidmarsh-out-as-us-fda-drug-center-director-MI2NEWEM6ZFP7GP66ZQJL76N2Q/ ...

2025-11-0735 min

Cross Border Compliance with Attorney Benjamin L. England Government Shutdown Impact: How FDA and Customs Operations Are AffectedEpisode Summary: In this episode of FDA Imports: Cross Border Compliance, Benjamin England breaks down how the ongoing federal government shutdown is affecting the FDA and U.S. Customs and Border Protection. Drawing on his experience as a former FDA regulatory counsel, Benjamin explains how much of the FDA’s operations continue due to user fees and why import enforcement remains active even during a shutdown. He outlines which inspections are still taking place, which types of products are being prioritized, and how the shutdown impacts imported goods ranging from foods and drugs to cosmetics and me...

2025-10-2819 min

FDA Watch A Look at FDA's Drug Review Reset Wayne chats with Cartier Esham, CEO of Esham Strategies and Executive Director of the Alliance for a Stronger FDA, and Elizabeth Jungman, Partner at Hogan Lovells in the firm's Pharmaceuticals and Biotechnology practice. You'll hear their thoughts on FDA's maintenance of its drug review process amid staffing cuts; the agency's new PreCheck program and how it may proceed; FDA's evolving stance on confirmatory evidence and accelerated approvals and how they could reshape how companies approach clinical trial designs or risk disclosures; agency budgets; ramped-up AI use at the agency and in industry; and much more. In our...

2025-10-2045 min $biobalancehealth\'s podcast$

biobalancehealth's podcast What happens when a doctor can't find an FDA approved drug to treat a condition they are faced with?See all the Healthcasts at https://www.biobalancehealth.com/healthcast-blog If you ever doubted your doctor because she wrote a script that you later "Googled" and found was not FDA approved, I hope you trusted your doctor enough to realize that she wouldn't recommend any medication that would hurt you…. What is an unapproved use of a drug, also called "off-label"? Unapproved use of an approved drug is often called "off-label" use. This term can mean that the drug is: Used for a disease or medical condition that it is not approved to tr...

2025-10-1628 min

PTN Logistics FDA Là Gì? Tấm Vé Thông Hành Cho Hàng Xuất Khẩu Vào MỹXin chào các bạn, chào mừng đến với Podcast PTN Logistics.Trong tập hôm nay, chúng ta sẽ cùng nhau khám phá một yếu tố quyết định sự thành bại của lô hàng xuất khẩu sang Mỹ – đó chính là FDA.Nếu bạn đang tìm hiểu về thị trường Mỹ, chắc hẳn đã nghe đến ba chữ cái FDA. Nhưng FDA là gì? Vai trò của nó ra sao? Và làm thế nào để tuân thủ đúng quy trình để hàng hóa không bị từ chối nhập khẩu? Hã...

2025-10-0302 min

Skinfluenced - The Skin Podcast Press Release: FDA Approves Remibrutinib (Rhapsido) for Chronic Spontaneous UrticariaDisclaimer: This podcast is not sponsored by or associated with any of the products mentioned in today’s episode.In this episode of Skinfluenced: The Skin Podcast, we review the FDA’s September 30, 2025 approval of remibrutinib (Rhapsido, Novartis), the first oral BTK inhibitor indicated for chronic spontaneous urticaria (CSU). We’ll walk through the press releases, clinical trial data, and recent publications highlighting its efficacy, safety, and potential impact on treatment pathways for CSU.Link to Source(s):The American Journal of Managed Care (AJMC). FDA Approves Remibrutinib for Chronic Sponta...

2025-10-0213 min

The Skeptics Guide to Emergency Medicine SGEM Xtra: Tell Me Lies, Sweet Little Lies – FDA Approved & IneffectiveDate: August 12, 2025 Article: FDA Approved and Ineffective by Jeanne Lenzer and Shannon Brownlee. June 5, 2025. The Lever. Jeanne Lenzer Guest Skeptic: Jeanne Lenzer is a long-time medical investigative journalist and returning SGEM guest. Her previous work, including the book The Danger Within Us, explored how conflicts of interest and weak evidence can endanger patient care. In this new project with The Lever, Jeanne analyzes how the FDA approves drugs that often don’t meet basic efficacy standards. I think many people assume that if a treatment is FDA-approved, surely it must work. However, people may be shocked to find out about the F...

2025-09-1452 min

FDA Watch FDA's Fight Against Ultraprocessed Foods Wayne chats with Claudia Lewis, Co-Chair of the FDA Group at Venable, and Ricardo Carvajal, Director at Hyman, Phelps & McNamara. You'll hear their thoughts on FDA's focus and direction on ultraprocessed foods; GRAS regulation and former FDA Commissioner Dr. David Kessler's citizen petition; potential agency updates to food nutrition labeling; inspections and food safety; FDA's use of AI in food decision-making; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Substantial publicity surrounds firing of CDC Director Susan Monarez Devices: FDA launces Regulatory Accelerator for digital health devices

2025-09-0844 min

FDA Watch Vaccines, Pharmaceutical Policy & FDA's Next Moves Wayne chats with Deb Autor, CEO of Healthcare Innovation Catalysts, and Paul Offit, M.D., Director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at the Children's Hospital of Philadelphia. You'll hear their thoughts on vaccine development, policy, testing, and funding, including COVID vaccines; the new Commissioner's National Priority Voucher Program; the Sarepta gene therapy episode; leadership transitions at CDER and CBER; AI in pharmaceutical regulation; and much more. In our headlines segment, Wayne delves into these major developments: Pharma: Vinay Prasad back as CBER head after ousting

2025-08-1141 min

FDA Watch FDA's Past, Present & Future with John Taylor Wayne chats with John Taylor, Head of the Quality and Compliance Practice at ELIQUENT and 30-year FDA, industry, trade association, and consulting veteran. Together, they discuss Taylor's pedigree; his perspective on the most pressing issues FDA is facing in drugs, devices, foods, and cosmetics; the agency's increasing use of AI; what FDA's top priorities should be moving forward; and much more. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be...

2025-08-0748 min

说医解药一家生物制药公司如何困住了3位FDA高官 Vol.332025年7月29日，美国食品药品管理局生物制品评价与研究中心（CBER）主任Vinay Prasad被媒体曝光去职。此时距5月6日Prasad执掌CBER不到3个月，大概创下了CBER主任最短任期纪录。CBER负责审批、管理美国的生物制剂类药品，包括血液制剂、疫苗、基因治疗、细胞治疗，在FDA的重要性仅次于负责绝大多数药品管理的药物评价和研究中心（CDER）。CBER主任也是FDA管理层核心。Prasad的离任非常突然：上任后，他混得极为风光，除了CBER主任，还加上了FDA首席医学官与首席科学家头衔。似乎成了特朗普、小肯尼迪的让美国再度健康（MAHA）运动里的明星小将。这样一位炙手可热的高官，怎么就突然下课了呢？这和一家生物制药公司脱不了干系，更神奇的是，这家并非制药巨头的生物技术公司，不到10年间，“困”住了3位FDA高官。这既是一个关于罕见病，患者权益的故事，也是一个考验药品监管原则的故事。我们今天就来聊聊一个罕见病里多个药物的是是非非。本期故事的一些关键角色：DMD：杜兴氏肌营养不良症（Duchenne Muscular Dystrophy），一种主要影响男孩的罕见病，由DMD基因上的突变导致，经典的X染色体隐性遗传病Sarepta：美国生物制药公司，专注于罕见病，尤其是DMD的药物研发Elevidys：治疗DMD的基因治疗，用AAV病毒载体引入一个小型DMD基因，目前接受过该药治疗的患者超过900人。其中已不能独立行走的DMD患者约150人，发生2例急性肝衰竭死亡Zolgensma：治疗脊髓性肌萎缩症（SMA）的基因治疗，2019年上市，全球第一个年销售额超过10亿美元（重磅药物的销售额标准）的基因治疗，2022年曝出2例急性肝衰竭死亡，当时接受该药治疗的患者总数约2300人AAV：基因治疗里最常用的病毒载体，用于引入基因Janet Woodcock：前FDA代理局长，曾长期管理CDER，在FDA现代化中居功至伟，但因2016年力排众议批准Sarepeta的第一个DMD药物受到非议Peter Marks：前CBER主任，2025年3月因不满小肯尼迪的反疫苗立场离职。23年与24年两次力排众议，批准Elevidys的加速审批和全面批准以及人群扩展，受到非议Vinay Prasad：前CBER主任，血液肿瘤医生背景，任内否决FDA科学家意见，缩小新冠疫苗适用人群。Elevidys肝衰竭风险引发关注后强力推动全面暂停Elevidys使用，引发特朗普阵营里多方极度不满，被特朗普点名下课这期节目里，你会听到【🎙️时间轴】：00:58 MAHA红人垮台：CBER是什么机构，CBER主任的江湖地位05:09 杜兴氏肌肉营养不良症（DMD）Sarepta公司专注于DMD这种罕见病。DMD由编码Dystrophin蛋白（抗肌萎缩蛋白）的DMD基因突变导致。抗肌萎缩蛋白对维持肌肉细胞的结构和功能至关重要。DMD患者中，由于抗肌萎缩蛋白不再有正常功能，肌肉会萎缩退化。作为X染色体隐性遗传病，DMD的普遍遗传规律是母亲携带突变的DMD基因，把突变基因传给了儿子，后者发病。每3000-5000名男孩中会有一人患病08:30 “跳跃”的争议Sarepta现在有4个药物获得FDA批准，全部针对DMD。3个属于外显子跳跃药物。Sarepta的第一个外显子跳跃药物eteplirsen申请上市时，FDA提出希望用随机对照试验显示eteplirsen确实改善了患者的身体状况。Sarepta则希望通过和历史对照比较、患者个人体验、以及患者体内开始表达外显子跳跃的蛋白，这些“另类”指标来证实有效性。2016年，FDA召开外部专家会，专家投票反对批准eteplirsen。FDA内部科学家也不认可Sarepta提供的证据。但当时主管CDER的Janet Woodcock否决了FDA内部科学家意见，力排众议批准eteplirsen上市。这是Woodcock漫长职业生涯里最具争议的决定之一。15:28 是非Elevidys：加速批准的争议；基因治疗的小庙装不下DMD这尊大佛；临床试验失败却获得转正2023年，Sarepta的DMD基因治疗Elevidys获得FDA加速批准，用于4-5岁尚能行走的DMD患者。FDA的加速批准是基于生物标记物而非传统疗效的特殊审批模式，在Elevidys这里，是基于患者表达了该基因治疗引入的DMD蛋白。该标准充满争议。更出人意料的是，后续3期临床试验失败后，FDA不仅没有撤回Elevidys的4-5岁尚能行走患者的加速审批，反而将其扩展到全年龄段能行走的患者并转正成为全面获批，同时另外增加了针对已无法行走的DMD患者的加速审批。该决定又是全凭一位FDA高官的力推——时任CBER主任Peter Marks。22:42 DMD家属作为罕见病，DMD患者组织拥有的惊人能量不在于人数众多，而在于这些少数人具有百分之百的专注与热情。25:05 肝衰竭风险凸显Elevidys这类基因治疗，是给患者引入大量病毒载体，这些病毒载体一方面可能激发强烈的免疫反应，另一方面往往会聚集到肝脏，综合在一起，存在不可忽视的肝脏毒性风险。27:40 Elevidys危机急转直下7月16日，在FDA的要求下，Sarepta给Elevidys加上了急性肝损伤与肝衰竭的黑框警告，这是FDA要求展示药物不良反应警告里最强的警告模式。7月18日，FDA局长Martin Makary在接受澎博社采访时表示正在考虑是否要撤销Elevidys的上市许可。同一天，FDA联系Sarepta，要求其主动暂停Elevidys发货。当日晚，Sarepta发布新闻稿，拒绝FDA的停止供货要求，重申在可独立行走的DMD患者中，Elevidys没有遇到新的安全问题，因此应该继续为这部分患者提供药物。7月21日，“为了维持与FDA的良好工作关系”，Sarepta宣布全面中止Elevidys在美国的发货，两天后，负责国际销售的合作伙伴罗氏宣布在国际市场也暂停销售。无数次逆天改命的Sarepta似乎终于陷入了一个无法突破的重围。31:29 风向突变7月25日，FDA再度发表声明，表示巴西有1名8岁孩童接受Elevidys治疗后死亡，将对此启动调查。7月28日，仅仅过了一个周末，FDA宣布调查结束，巴西8岁男孩的死亡与Elevidys无关，同时允许恢复在具有自主行走能力的患者中使用Elevidys。7月29日，一直质疑Elevidys的Prasad被证实离职。33:14 患者组织发力Prasad主管CBER后，该机构的一些决定就与特朗普支持者以及MAHA阵营里不可小觑的right to try（试验权）势力有了冲突。Elevidys事发后，矛盾大暴发。而把这种理念冲突瞬间放大，整合多支原本并无交集的保守派力量，发起致命一击的，显然仰赖强大的DMD患者组织38:04 Prasad的行为也难言科学针对病毒载体的免疫反应导致肝脏毒性是所有AAV载体基因治疗的通病。仅因出现急性肝衰竭就要某个基因治疗下市，与过往基因治疗的管理方式矛盾。2例肝衰竭病例都出现在已经不能行走的DMD患者中。Elevidys获批用于还能独立行走的患者更早，接受过该治疗的这类患者更多，超过700人，未发现肝衰竭。这种差异可能是和使用剂量有关。与绝大多数基因治疗一样，Elevidys按体重给药，失去独立行走能力的DMD患者年龄更大，体重更高，就会注射更多的药物，AAV病毒颗粒，也带来了更强免疫反应，以及肝毒性问题FDA行动的一些时间点让其决策动机

2025-08-0750 min

FDA Watch AI, Medical Products & FDA, Part 3: AI in Drug & Device Commercialization In this third and final part of our AI series in collaboration with Arnold & Porter, Shelly and Wayne chat with Philip Desjardins, Partner at Arnold & Porter; Mahnu Davar, Partner at Arnold & Porter; and Dr. William Maisel, Vice President and Senior Medical Officer at Intuitive, and former Director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health at FDA. Together, they discuss the use of AI for clinical decision support, in regulation and pharmacovigilance functions, and in diagnostic and monitoring tools; AI's impact on advertising and promotion; what "AI washing" is and why...

2025-05-2739 min

FDA Watch AI, Medical Products & FDA, Part 2: AI Discovery, Design & Development In this second part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Howard Sklamberg, Partner at Arnold & Porter; Eva Temkin, Partner at Arnold & Porter; and Marko Topalovic, Chief AI Officer at Clario, which recently acquired ArtiQ, where he was Founder and CEO. Together, they discuss how AI can accelerate drug discovery and design; how AI could be used in the clinical trial process; how FDA could use AI to evaluate medical product manufacturers' data integrity operations and in inspections; how AI could play a part in product applications; and much more. ...

2025-05-0143 min

Citeline Podcasts Drug Fix: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ ApprovalPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of the departures of several senior leaders in the US Food and Drug Administration’s facility inspection group, Office of Generic Drugs and Office of Prescription Drug Promotion (:26). They also consider Commissioner Martin Makary’s intent to combine the agency’s many adverse event databases (14:52), his idea for a new approval pathway based on a “plausible mechanism” (26:25) and the seemingly increasing influence of politics at the agency despite his declarations that the FDA is apolitical (36:16). More On These Topics From The Pink Sheet US F...

2025-04-2541 min

FDA Watch The State of Protection, Innovation & Communication at FDA Shelly and Wayne chat with Ron Bartek, Co-Founder and President of Friedreich's Ataxia Research Alliance, and Ralph Hall, CEO of Hall Strategies, LLC. Together, they discuss the overall situation at FDA right now; its impact on agency activities and innovation; what areas will be most impacted; what policy changes, such as those surrounding vaccines, animal testing, expedited approvals, and right-to-try guidance, might be coming; and much more. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments. To subscribe or find out more information about our podcast, visit FDAWatch...

2025-04-1733 min

FDA Watch AI, Medical Products & FDA, Part 1: AI Overview in Life Sciences In this first part of our AI-focused series in collaboration with Arnold & Porter, Shelly and Wayne chat with Dan Kracov, Partner at Arnold and Porter and Chair of the firm's Global Life Sciences Industry group; Abeba Habtemariam, Partner at Arnold & Porter; Ethan Dabbs, Managing Director and Senior Partner at the Boston Consulting Group; and Lauren Silvis, Senior Vice President of External Affairs at Tempus. Together, they discuss Arnold & Porter's recent survey on AI adoption in life sciences; problems, challenges, and successes in AI adoption in drug and medical device development; where FDA may be hampered in developing AI policy...

2025-04-1547 min

Healthcare Matters S6, Ep 4- Leadership, Layoffs, and the Future of the FDA: How Policy Turmoil Threatens Innovation and PatientsIn this episode of Healthcare Matters, hosts Dr. Robert Popovian and Ben Blanc are joined by Peter Pitts, former FDA Associate Commissioner and President of the Center for Medicine in the Public Interest. Together, they unpack the sweeping personnel cuts at HHS, ongoing instability at the FDA, and how it all may threaten the future of drug innovation in the U.S. With delays in leadership appointments, policy misalignment across agencies, and increased uncertainty from pricing reforms like the Inflation Reduction Act, pharmaceutical companies may hit pause—and patients may pay the price. Tune in for a ti...

2025-04-1126 min

Global Medical Device Podcast powered by Greenlight Guru #401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech IntegrityIn this compelling episode, Etienne Nichols chats with regulatory powerhouse Sarah Moeller about the crucial intersection between the FDA's regulatory oversight and international ISO standards development. They uncover the profound impact of FDA's participation—or absence—in shaping global standards, especially ISO 14155 and ISO 18969 updates. The conversation also tackles the shifting landscape caused by administrative changes in the U.S., the effects on clinical trials, AI-driven digital evidence, and what companies must do to stay compliant and innovative in a volatile regulatory environment.Key Timestamps:[02:30] – Introduction to Sarah Moeller and her role in ISO 18969 update...

2025-04-1048 min

Citeline Podcasts Drug Fix: Understanding The US FDA Reduction-In-Force And Its Long-Term ImpactPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs discuss the impact of the 1 April reduction-in-force on the US Food and Drug Administration, which targeted about 3,500 employees (:30). They also consider how and whether service levels will change (13:28), and new Commissioner Martin Makary’s first address to the drastically smaller staff the day after the RIF was announced (29:22). More On These Topics From The Pink Sheet Updated: US Likely To Lose Its First Approver Advantage After FDA Layoffs: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/fda-layoffs-us-likely-to-lose-its-first-approver-advantage-5C37YQ73DNBEFF7SHRYV4MJUIA/ Are Bi...

2025-04-0441 min

FDA Watch The Latest in FDA's Focus on Foods Shelly and Wayne chat with Dr. Susan Mayne, Adjunct Professor at the Yale School of Public Health and former Director of FDA's Center for Food Safety and Applied Nutrition, and Dr. Peter Lurie, President of the Center for Science in the Public Interest and former Associate Commissioner at FDA. You'll hear their thoughts on what incoming FDA Commissioner Dr. Marty Makary may be prioritizing in the food space, why it took FDA so long to ban Red Dye No. 3, the agency's "healthy" claim final rule, where FDA stands with reducing sodium in human foods, the push to eliminate the...

2025-03-3152 min

Citeline Podcasts Drug Fix: Buyouts, Departures and Other US FDA ChaosPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the US Food and Drug Administration’s early retirement and buyout programs to further cut its workforce (:25), leadership departures in the Center for Biologics Evaluation and Research (9:13), the quick arrival and resignation of a new FDA chief counsel (12:35), and Commissioner nominee Martin Makary closing in on confirmation, as well as the impact of the staffing changes on the agency he likely will be running (22:45). More On These Topics From The Pink Sheet US FDA Reviewers, Inspectors Not Eligible For HHS Buyouts: https://insights.citeline.com/pi...

2025-03-1431 min

Cross Border Compliance with Attorney Benjamin L. England Behind the Scenes: Customs Brokers and FDA RegulationsEpisode Summary: In this episode of FDA Imports: Cross-Border Compliance, attorney Benjamin L. England breaks down the complex regulations governing food imports into the U.S. He explains the distinct roles of the FDA and USDA, focusing on key compliance areas such as adulteration, misbranding, and the pre-import permit process. Listeners will gain insight into how food safety regulations apply to different products, including high-risk categories like seafood, fresh produce, and canned foods. England also discusses the FDA’s sampling and enforcement process, labeling requirements, and the consequences of non-compliance at the border. Timestamps: 00:00 – Introduction to FDA Imports: Cros...

2025-03-1019 min

FDA Watch Navigating FDA's Future: Janet Woodcock on the Evolving Regulatory Landscape Shelly and Wayne chat with Janet Woodcock, M.D., former FDA Principal Deputy Commissioner. Woodcock shares her expert insights on the agency's approach to navigating the current regulatory environment, the increasing role of artificial intelligence in FDA decision-making, and the future of the agency's staffing, resources, and regulatory frameworks. This episode and all future bonus episodes do not include the usual Headlines and Resource Links segments. To subscribe or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the...

2025-02-1739 min

Cross Border Compliance with Attorney Benjamin L. England Importing FDA-Regulated Products: Understanding FDA and Customs Enforcement ActionsEpisode Summary In this episode, Benjamin England discusses the complexities of FDA import regulations, enforcement actions, and the risks that businesses face when importing FDA-regulated products into the U.S. He covers the authority FDA has at the border, how FDA detains or refuses shipments, the importance of bonds, and the consequences of non-compliance. Benjamin also provides insight into how importers can navigate FDA enforcement, handle violations, and prevent future issues. Timestamps: [00:00-00:30] Introduction to the topic of FDA import regulations and enforcement. [00:31-02:50] Benjamin England discusses the scope o...

2025-02-0725 min

FDA Watch The New-Look FDA: What's on the Horizon? In this episode, Shelly and Wayne chat with Marc Scheineson, a former FDA Associate Commissioner and currently Senior Counsel in the Washington, D.C., office of Alston & Bird; and Steven Grossman, President of HPS Group, a policy and regulatory consulting firm, and author of "FDA Matters: The Grossman FDA report." You'll hear their thoughts on what to expect from FDA under the new administration, including the transition process, Robert F. Kennedy Jr.'s role, staffing issues, funding, possible changes in standards for safety and efficacy, the fate of user fees, and more. This episode and a...

2025-01-2043 min

Citeline Podcasts Drug Fix: US FDA And Trump’s Reforms, CDER Director Parting Comments, 2024 Approval TrendsPink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms (:24), comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters (12:35), and diverging trends between CDER and CBER novel application approvals (21:53). More On These Topics From The Pink Sheet Trump’s US FDA Reforms Need Center Director, Staff Support To Succeed, Former Leaders Say: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/trumps-us-fda-reforms-need-center-director-staff-support-to-succeed-former-leaders-say-VCCGXSBJGZGXPHEYJFAHIHEI7A/ Exit Interview: US FDA’s Patrizia Cavazzoni Says CDER Staff In ‘Best Place Possible’: https://insights.citeline.com/pink-sheet...

2025-01-1737 min

Yale Certificate in Medical Software and Medical AI: Guest Experts The FDA and Software: A Historical Overview with Dr. Donna-Bea TillmanThis video is part of a series of guest expert interviews that we recorded for our new Yale Certificate Program on Medical Software and Medical AI – https://online.yale.edu/medical-software-ai-program. Our guest is Donna-Bea Tillman, a principal consultant at Biologics Consulting Group. She has 30 years of medical device regulatory experience. Prior to joining Biologics Consulting she held numerous positions within FDA’s Center for Devices and Radiological Health, culminating in her 2004 appointment to the position of Director of the Office of Device Evaluation, where she oversaw the medical device premarket review program for non-IVD devices. During her...

2025-01-1538 min

Cross Border Compliance with Attorney Benjamin L. England FDA and Customs: The Dynamic Duo Behind Smooth ImportsEpisode Summary In this episode, Benjamin England, founder of FDAImports.com, provides an in-depth look at the FDA and customs regulations for importing FDA-regulated products into the U.S. He explains the roles of customs brokers, the FDA, and Customs and Border Protection (CBP), outlining key steps importers need to take for smooth and compliant importation. Benjamin also shares valuable tips on maintaining product safety, meeting regulatory requirements, and ensuring truthful labeling and marketing. Whether you’re importing food, pharmaceuticals, or medical devices, this episode is packed with actionable insights for navigating the complexities of U.S. import la...

2025-01-1024 min

Citeline Podcasts Drug Fix: CDER Director Retires, US FDA Guidance ‘Blizzard,’ Rare Pediatric Disease Program Hangs OnPink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni’s surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA’s decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48). More On These Topics From The Pink Sheet Digging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/ Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/ ...

2025-01-1025 min

The Passionate Workforce Podcast Expert Insights on FDA Regulations and Building a Passionate WorkforceIn this special cross-post episode of The Passionate Workforce Podcast, we’re excited to share Nick Capman’s recent conversation from Steve Ramona’s podcast, Doing Business with a Servant’s Heart. Nick delves into two critical topics: expertly navigating FDA regulations and building a passionate, high-performing workforce. Nick shares his deep experience in helping life sciences companies streamline their regulatory processes, prevent costly delays, and achieve smoother approvals. Shifting gears, the episode explores how business leaders can transform workplace culture by embracing bold strategies like profit-sharing and unlimited paid time off. Whether you're in the FDA-regulated industry...

2024-10-2428 min $ATGC doctors\' chat$

ATGC doctors' chat 监管、药企和患者是新药研发的不可能三角么？｜与FDA专家聊聊创新药的审评与上市（上） E41我们的节目一直关注新药研发的各个环节，从最初的基础研究到最后的上市。今天的嘉宾是一位在新药研发领域拥有丰富经验的专家肖申博士。肖博士曾在美国 FDA 担任新药临床审评专家，并在回国后担任药企的首席医学官。他的职业经历涵盖了监管和企业两个重要方面，使他能够从多个维度深入探讨创新药物的研发、审评和上市。节目分成上下两集，上集的节目肖博与我们分享了一个新药要在美国上市需要经历的层层考验，中美两国对新药审评的一些比较，以及他在工作中曾经遇到过的特别有趣和值得思考的审评案例。下集的节目肖博跟我们聊了聊他从监管机构转换到企业工作所看到的新药开发的不同侧面，以及中国创新药面临的挑战。👨【本期嘉宾】肖申，前FDA高级研究员，海森生物首席医学官🎙️【时间轴】02:56 从FDA研究员到药企CMO，肖申博士的职业经历05:12 一个新药在美国上市需要经历哪些阶段？哪些阶段需要与FDA打交道？07:17 FDA-患者-药企之间的三角关系, FDA的功能与角色11:25 中美药物监督局的比较19:51 阿杜那单抗一波三折的药品申报史25:31 盐酸替纳帕诺片：两次被拒，给FDA告状也不行36:53 孤注一掷：Veverimer的申报命运💊【我们提到】Aducanumab，中文名阿杜那单抗2020 年 11 月，因没有足够的临床数据支持该药的有效性，FDA 药物咨询委员会几乎一致投票反对批准 aducanumab；但是其临床获益的替代终点，FDA 于 2021 年 6 月批准了使用加速批准途径治疗阿尔茨海默病；由于市场需求低迷和报销挑战，在2023 年 1 月宣布该药在美国的销售。Tenapanor，中文名盐酸替纳帕诺片用于治疗肠易激综合征和终末期肾病患者的高磷血症，因为临床意义不明显，两次被拒。Veverimer治疗慢性肾病患者的代谢性酸中毒。有效提高了 CKD 患者的血清碳酸氢盐水平，根据这一替代终点，获得了FDA 加速的批准；因为对Veverimer临床益处的怀疑，FDA拒绝了新药上市申请（NDA）📖 【相关单集】创新药高考: 浅聊新药的临床试验、监管与上市 E23📖 【相关资料】 https://www.fda.gov/drugs/our-perspective/fdas-decision-approve-new-treatment-alzheimers-disease https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-alzheimers-drug https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000MultidisciplineR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/211801Orig1s000MultidisciplineR.pdf https://www.fda.gov/drugs/our-perspective/fdas-decision-approve-new-treatment-alzheimers-disease https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10193636/📬【联系我们】商业合作：zyx3200@163.com微信：atgcdoctorschat，备注「加听友群」

2024-10-2245 min

Broken Truth Flashback: The Fifth Circuit Court of Appeals Forced the FDA to Admit Doctors Can Prescribe IvermectinRemember when the FDA went on a full-court press to stop any treatments for Covid, like Ivermectin or Hydroxychloroquine? We do. Three judges in the Fifth Circuit Court of Appeals do as well.In August of 2023, Ashley Cheung Honold with the Department of Justice represented Health and Human Services in the lawsuit appeal between Dr. Mary Bowden and other doctors against the FDA's misrepresentation of ivermectin and the public consequences that occurred from it. At one point in the misinformation campaign created by the FDA and its acolytes in the media, the FDA tweeted "You are not...

2024-08-1048 min

Supreme Court Decision Syllabus (SCOTUS Podcast)FDA v. Alliance for Hippocratic Medicine (Birth Control)Send us a textFDA v. Alliance for Hippocratic MedicineIn 2000, the Food and Drug Administration approved a new drug application for mifepristone tablets marketed under the brand name Mifeprex for use in terminating pregnancies up to seven weeks. To help ensure that Mifeprex would be used safely and effectively, FDA placed additional restrictions on the drug’s use and distribution, for example requiring doctors to prescribe or to supervise prescription of Mifeprex, and requiring patients to have three in-person visits with the doctor to receive the drug. In 2016, FDA relaxed some of th...

2024-06-1811 min

Live Longer World FDA History and Breast Cancer Drug Controversy | Dr. Mikkael SekeresDr. Mikkael Sekeres is the author of the book The Drugs and FDA. He served as the chair of the Oncology Drugs Advisory Committee of the FDA, and was on the jury for the controversial trial of the breast cancer drug Avastin. We discuss: - The history of the FDA, - The trial of Avastin which got FDA approval in 2008 and revoked in 2011 - FDA's funding mechanisms - FDA ties to big pharma - What can be improved about the FDA and the criticisms it receives Episode Show Notes: https://livelongerworld.com/p/msekeres TIMESTAMPS: 0:00 Surprising finding...

2024-04-241h 05

Food Safety Matters Ep. 167. James (Jim) Jones: Engaging Stakeholders for a Unified FDA Human Foods Program James (Jim) Jones joined the U.S. Food and Drug Administration (FDA) in September 2023 as the agency's first Deputy Commissioner for Human Foods. In this position, he leads the charge in setting and advancing priorities for a proposed, unified Human Foods Program, which includes food safety, chemical safety, and nutrition activities. He currently oversees the leadership of the Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Food Policy and Response (OFPR), until the proposed Human Foods Program reorganization is implemented. Jones came to FDA with intimate knowledge of the Human Foods program, having...

2024-04-0954 min

Citeline Podcasts Drug Fix: Janet Woodcock retiring, Accelerated Approval Reform, US FDA Meeting Recording PolicyPink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches (:42), the stance of the FDA’s oncology division on confirming benefit after an accelerated approval (16:59), and why formal meetings between the agency and sponsors cannot be recorded (36:51). More On These Topics From The Pink Sheet With Woodcock’s Retirement, US FDA Loses A Renaissance Woman: https://pink.citeline.com/PS149368/With-Woodcocks-Retirement-US-FDA-Loses-A-Renaissance-Woman Confirmatory Trial Plan For Acrotech’s Folotyn, Beleodaq Needs Rethinking, FDA Panel Says: https://pink.citeline.com/PS149361/Confirmatory-Trial-Plan-For-Acrotechs-Folotyn-Beleodaq-Needs-Rethinking-FDA-Panel-Says FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirma...

2023-11-1743 min

Citeline Podcasts Drug Fix: US FDA Suffers From Shutdown Threat, Alnylam’s CR Letter, ARPA-H Wants FDA IncentivesPink Sheet reporters and editor discuss the problems that emerged for the US FDA from just the threat of a government shutdown (:38), take-aways on the FDA advisory committee process based on the complete response letter issued for Alnylam’s Onpattro (10:25), and incentives that the FDA could offer for ARPA-H projects that reach the application stage (20:16). More On These Topics From The Pink Sheet Shutdown Threat Forced US FDA To Cancel Some Travel: https://pink.citeline.com/PS149003/Shutdown-Threat-Forced-US-FDA-To-Cancel-Some-Travel Alnylam’s Complete Response Is Classic Example Of FDA-Advisory Committee Disagreement: https://pink.citeline.com/PS149000/Alnylams-Complete-Response-Is-Classic-Example-Of-FDA-Advisory-Committee-Disagreement US FDA Rejects Onpattro Label Expa...

2023-10-1330 min

From The Dunya To The Akhirah | FDA FDA Podcast Ep2 | Conspiracy theoriesIn this episode we share some of our own conspiracy theories as well as reading some we found on reddit. Enjoy!

2023-09-1038 min

From The Dunya To The Akhirah | FDA FDA Podcast Ep1: Muslim Marriage Horror StoriesIn this episode we'll read reddit stories about muslim marriage horror stories. Some of this content will be of serious topics so viewer discretion is advised.

2023-08-201h 01

FedSoc Forums Dueling Decisions on the Regulation and Distribution of Mifepristone: AHM v. FDA & WA v. FDATwo cases concerning the FDA’s approval of Mifepristone, Alliance for Hippocratic Medicine v. United States Food and Drug Administration (AHM v. FDA) and Washington v. United States Food and Drug Administration (WA v. FDA) have caused significant conversations concerning the FDA’s approval processes, statutes of limitation for challenges to approvals, standing, administrative review, and judicial authority. The cases present interesting questions concerning the regulatory process, separation of powers, and the role of judges. In AHM v. FDA, a judge out of the Northern District of Texas blocked the FDA’s approval of the drug, meaning it could...

2023-06-2156 min

Food Safety Matters Ep. 142. Dr. Donald Prater: FDA's Import Food Safety, Culture, and Smarter Tools Donald A. Prater, D.V.M. is Acting Director of the Office of Food Policy and Response (OFPR) at the U.S. Food and Drug Administration. Since 2019, he has also served as Associate Commissioner for Imported Food Safety in OFPR, providing direction to and management of imported food safety programs. In addition, he served as a senior scientific advisor and technical expert on matters related to human and animal food safety and the implementation of the FDA Food Safety Modernization Act (FSMA). Before joining OFPR, Dr. Prater was the Assistant Commissioner for Food Safety Integration, serving as...

2023-04-111h 08

Food Safety Matters Friedlander and Lasprogata: FDA and Industry Perspectives on FSMA 204Adam Friedlander is a Policy Analyst in FDA's Coordinated Outbreak Response and Evaluation (CORE) Network, where he helps lead the agency's efforts to advance strategic, tech-enabled traceability initiatives under the New Era of Smarter Food Safety. Through collaboration and by leveraging the power of data, he hopes to help transform the food system to become more digital, transparent, and safe for consumers around the world. Adam graduated from Cornell University with a B.S. degree in Food Science and Operations Management and a minor in Music. He received his M.S. degree in Regulatory Affairs of Food and Food...

2023-01-3154 min

Onc Nurse on Call A Look Back at 2022 FDA Approvals in OncologyIn this special episode of “The Vitals,” we ring in the New Year by combing through 2022 FDA approvals. Listen as associate editor, Lindsay Fischer, recounts key approvals on a month-by-month basis, with input from some of the investigators from behind the research. To read the full information surrounding the approvals, be sure to check out our news coverage below. Other resources can also be found below. As always, thank you for listening to The Vitals, and for all the engagement in 2022. We look forward to bringing you more oncology news in 2023. We want to hear from you! Which drugs...

2023-01-0223 min

Oncology Nursing News: The Vitals A Look Back at 2022 FDA Approvals in OncologyIn this special episode of “The Vitals,” we ring in the New Year by combing through 2022 FDA approvals. Listen as associate editor, Lindsay Fischer, recounts key approvals on a month-by-month basis, with input from some of the investigators from behind the research. To read the full information surrounding the approvals, be sure to check out our news coverage below. Other resources can also be found below. As always, thank you for listening to The Vitals, and for all the engagement in 2022. We look forward to bringing you more oncology news in 2023. We want to hear from you! Which drugs...

2023-01-0223 min

林氏璧孔醫師的日本旅遊情報站 220902 次世代疫苗該選BA.1還是BA.5雙價？美國FDA給予莫德納，輝瑞/BNT疫苗BA.5雙價疫苗緊急授權美國時間8月31日的大新聞，我必須承認我完全被嚇到了。 1.美國FDA通過了莫德納和BNT的含BA.5雙價疫苗。這次通過不太尋常，沒有開外部專家諮詢會議，直接開記者會發新聞稿宣布，和美國這兩年多來通過疫苗強調透明公共參與都不一樣。 2.時間回到今年六月，我和大家分享過當時FDA開會時廠商拿出BA.1的資料，但FDA投票決定應該要針對BA.5作為美國秋天的加強針，希望能在10月開打。 3.FDA聲稱通過此EUA是基於動物試驗，之前BA.1雙價的少人數臨床試驗，還有過去兩年廣泛的單株疫苗施打經驗。由於時間不夠，目前新的雙價疫苗還沒有在人的臨床試驗資料，僅做完動物試驗。 4.這個雙價疫苗包括一半原始株，另一半是BA.4/BA.5的共同部分。莫德納雙價疫苗兩者分別是25微克（共計50微克），輝瑞/BNT分別是15微克（共計30微克）。 5.施打對象：定位為加強針的更新（updated boosters）。莫德納可供18歲以上者接種，輝瑞的施打年齡則是12歲以上，必須在接種完基礎劑疫苗兩劑或最新一劑追加劑疫苗至少兩個月後才能施打。 6.由於學校開學，以及天氣轉涼後民眾會待在室內較長時間，疫情可能再度升高，美國政府已訂購1億500萬劑輝瑞和6600萬劑莫德納二價疫苗。基於後續資料，預期在1~2個月後會繼續將適用年齡往下。 7.其他國家都和美國採取不同作法。WHO建議使用BA.1即可，現在英國，瑞士，澳洲都批準了莫德納的BA.1雙價疫苗，這也是台灣明天會開會討論的次世代疫苗。日本也預計搶九月就打這款。這兩間mRNA公司都打算兩種次世代疫苗都供應，BA.5雙價給美國，BA.1雙價給其他國家。 04b解讀： 1.FDA記者會上多次強調他們對這樣的換株有信心，因為流感就是這樣行之有年的換株。且這兩間公司也累積了一些換株的經驗，比方說針對Beta，BA.1的經驗，看起來安全性和抗體生成性都不錯。但我個人是有存疑的，mRNA這個技術之前累積大量經驗是單價疫苗，雙價疫苗累積經驗畢竟不夠多，沒有大量上市施打的經驗，是否能直接比照流感疫苗換株不需要經過臨床試驗的理所當然？ 2.當然美國考慮的也不無道理，目前BA.1早已消失在世界上，流行的已經是BA.5，針對最符合目前流行的病毒株理論上效果會較好。未來新冠病毒肯定會不斷突變，累積經驗後換株就會變成和每年季節性流感一般，這我都同意。但問題就是，我們已經累積足夠經驗了嗎？ 3.一定有人會問，台灣目前在審在談的是BA.1雙價。我們需要換成BA.5雙價嗎？以台灣來說，我覺得可能不需要。我們五月大流行的是BA.2，BA.2和BA.5比較近似，和BA.1比較不同。如果以針對未知的下一株變異株的準備來說，打一個和BA.2不太一樣的BA.1學理上可能可以引發更廣泛的抗體。 4.且台灣疫情已經在升溫，能夠馬上拿到疫苗開始針對需要的人注射可能比較重要。若要換成BA.5雙價，又不知道要等到何時。 5.世界怎麼跟得上美國！就讓美國人當沒有經過臨床試驗就要開打的白老鼠吧。如果後續資料顯示安全性和有效性都沒有問題，那就是確立了以後新冠疫苗換株可以做完動物實驗就開打了。讓我們感謝勇敢的美國人吧！美國FDA記者會 https://youtu.be/QNFES1RLf1M FDA Authorizes Moderna, Pfizer-BioNTech Bivalent COVID-19 Vaccines for Use as a Booster Dose https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-moderna-pfizer-biontech-bivalent-covid-19-vaccines-use STATNEWS FDA authorizes Pfizer and Moderna Covid boosters targeted against Omicron strains https://www.statnews.com/2022/08/31/fda-authorizes-pfizer-moderna-covid-booster-targeted-against-omicron-strains/ Eric Topol的意見 https://erictopol.substack.com/p/the-imminent-ba5-vaccine-booster Omicron booster shots are coming—with lots of questions https://www.science.org/content/article/omicron-booster-shots-are-coming-lots-questions 歡迎追蹤前台大感染科醫師。04b的發聲管道！我的電子名片 https://lit.link/linshibi 希望大家當我的種子教師，推廣正確的新冠衛教。科學防疫，不要只以恐懼防疫！歡迎贊助林氏璧孔醫師喝咖啡，讓我可以在這個紛亂的時代，繼續分享知識努力做正確新冠相關衛教。 https://open.firstory.me/join/linshibi

2022-09-021h 05

林氏璧孔醫師的日本旅遊情報站 220701 FDA次世代疫苗會議建議美國秋天施打的加強針要針對Omicron病毒株1.美國FDA在6月28日開會，決定秋天應該要打怎樣的加強針。主要投票決定的問題是，下一個加強針是否應該要包含針對Omicron變種株？經過一整天檢視莫德納，輝瑞，Novavax三家廠商現有次世代疫苗數據，疫苗效力回顧還有對未來的疫情預測，最後以19票贊成、2票反對，建議美國秋天施打的加強針要含有針對Omicron病毒株。 2.WHO也來報告6月17日對次世代疫苗做出的建議。 https://www.who.int/news/item/17-06-2022-interim-statement-on--the-composition-of-current-COVID-19-vaccines 這集主要是以STATnews這篇會議記錄和評論來和大家解說 FDA advisory panel recommends Omicron-containing booster shots https://www.statnews.com/2022/06/28/tracking-an-fda-advisory-panel-meeting-on-updating-covid-vaccines/ 04b解讀： 1.建議要包含Omicron這個建議本身沒什麼建設性，完全是預料中的，輝瑞莫德納根本已經跑在你法規單位決定前就做了呀。討論的重點不是要不要包括Omicron，應該是肯定要包括，真正重要的問題是，是BA.1就好了還是需要建議用BA.4/BA.5？還有，到底是單價還是雙價疫苗好？會議中沒有針對後面兩個問題投票，只是讓專家各自表達意見。 2.目前疫苗公司做出的資料都是BA.1，但BA.1已經幾乎結束他的流行。現在是BA.2的尾巴，還有各種Omicron的衍生株。專家普遍似乎比較偏向雙價疫苗，還有要針對BA.4/BA.5，目前流行株來做次世代疫苗。主要理由是，BA.4/BA.5是目前免疫逃逸最嚴重的變種。目前初步資料看來，BA.1產生的抗體不太能防BA.4/BA.5，但反過來就可以。因此，FDA後來在6月30日正式建議秋天的加強針要針對BA.4/BA.5做。 3.麻煩的是，這和WHO立場不同。疫苗公司要聽誰的....還有，美國預計10月開打，BA.4/BA.5應該已經燒完了。這有意義嗎？來得及嗎？這兩間公司連BA.1都做了七個月才做到現在的成果，很顯然不是原本輝瑞聲稱的100天。我估計次世代疫苗出來的時間有可能會延遲。量產可能要到11月才上軌道，其他國家要打到就更晚了。 4.另外Sanofi最近直接用Beta單價就做出不錯結果，莫德納也有Beta的資料，但會議上似乎完全沒有討論到。殊為可惜。 FDA 6月28日開會討論次世代疫苗 https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-june-28-2022-meeting-announcement 最後的投票問題： Does the committee recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the United States? 反面意見 FDA: Don’t rush a move to change the Covid-19 vaccine composition https://www.statnews.com/2022/06/29/fda-dont-rush-to-change-covid-19-vaccine-composition/ 開會影片 https://youtu.be/BFdzNUus_CE 後續：6月30日FDA做出建議，次世代疫苗要針對BA.4/BA.5做 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-recommends-inclusion-omicron-ba45-component-covid-19-vaccine-booster 歡迎追蹤前台大感染科醫師。04b的發聲管道！我的電子名片 https://lit.link/linshibi 希望大家當我的種子教師，推廣正確的新冠衛教。科學防疫，不要只以恐懼防疫！歡迎贊助林氏璧孔醫師喝咖啡，讓我可以在這個紛亂的時代，繼續分享知識努力做正確新冠相關衛教。 https://open.firstory.me/join/linshibi

2022-07-0150 min

Making MedTech Happen with RQM+Live! #57 – FDA Appeals Process (featuring panelists from Linear Health and DuVal & Associates, PA)This is audio from RQM+ Live! #57, recorded 30 June, 2022. To join us live for future shows and ask your own questions, please view and sign up for upcoming events in the Knowledge Center at our website. At RQM+ we're often asked about the FDA appeals process and if it's worth the effort and perceived consequences. The thought of going head-to-head with FDA is intimidating, especially to small medical device companies trying for their first product clearance/approval. Our panelists recently supported a client with the appeals process and successfully overturned FDA's NSE (Not Substantially Equivalent) determination...

2022-06-3058 min

The Life Science Rundown FDA Revives Its Proposed Quality Metrics Program for PharmaThe FDA Group's Nick Capman discusses the recent news that the FDA is once again returning to its quality metrics program for pharma manufacturers. The agency’s focus on quality metrics began in 2015 and continued with a heavily revised draft guidance on submitting metrics data, including quality-related complaints. The guidance led to two FDA pilot projects in 2018. In a new update, FDA stressed that additional quality data can help both the FDA and the supply chain, which needs to have a better understanding of which manufacturers are going above and beyond the status quo.Cu...

2022-04-1807 min

Global Medical Device Podcast powered by Greenlight Guru Making Your Informational Meetings with FDA Valuable & WorthwhileWhat are informational meetings with the FDA, why should you schedule them, and how should they be conducted to make them valuable and worthwhile? It’s never too early to engage, interact, and collaborate with the FDA, or is it? In this episode of the Global Medical Device Podcast Jon Speer and Etienne Nichols talk to Isabella Schmitt, Director of Regulatory Affairs at Proxima and Principal at M1 MedTech.Isabella discusses the necessity of informational meetings and answers some commonly asked questions about them. Sometimes, it is too early to meet with the FDA if you...

2022-03-3136 min

Real Talk: Eosinophilic Diseases Drug Development and Approval: A Conversation with the FDAFor many subsets of eosinophilic associated disease, there is not yet an FDA-approved therapy available. There are several therapies in various stages of development for eosinophilic esophagitis, but what exactly are the steps that need to be taken to bring a therapy to market and what is the role of the U.S. Food and Drug Administration (FDA) in medications coming to market? In this episode, host Ryan Piansky, guest host Mary Jo Strobel, and Dr. Scott Winiecki discuss this topic. Dr. Scott Winiecki is the Director of the Safe Use Initiative at the FDA. He completed his M...

2022-02-2331 min

谭勇品读医药风云 FDA变脸，国产PD-1出海何去何从（上）2月10日，美国FDA肿瘤药物咨询委员会就礼来与信达的PD-1抑制剂信迪利单抗针对非鳞状非小细胞肺癌的BLA申请进行了投票表决。委员会投票建议需要在获批前补充额外临床试验，证明信迪利单抗在美国人群和美国医疗实践中的适用性。这也就是说，这场准备了两年多的出海尝试暂时以这种并不尽如人意的方式告一段落。但这并不是信达一家所面临的问题。作为国内第一个做PD-1大适应证去美国常规申报的中国创新药企，信达自然承担了更大的风险。但直到2021年12月之前，“一切进展得都相对顺利”。但去年12月，国内开始嗅到美国在国产PD-1出海这件事上的态度变化，风向忽然变了。最直接的声音来自FDA的官员。2021年12月16日，FDA肿瘤卓越中心主任理查德在接受媒体采访时指出，目前FDA新药获批中靠单一国家临床数据的情况“存在问题”，并点名中国。他表示这与美国倡导的在临床试验中增加患者多样性的原则“背道而驰”。理查德是FDA肿瘤药物审评中最具影响力人物，2005年FDA肿瘤卓越中心创立伊始便一直担任该机构主任。如此尖锐的声音从他口中发出，纵然不是官方正式声明也无异于向中国创新药出海这片池水中投下了巨石。2018年理查德曾到访中国，那时他还明确地“鼓励”中国公司将PD-1/PD-L1带入美国市场，与跨国大药企竞争来降低美国高昂的药品价格。他那时强调：“只要质量好，FDA一定会接受仅依靠中国临床数据的申请。” 2019年美国癌症研究协会举办的会议上，理查德再次公开表示“中国公司赴美竞争PD-1价格，可能对所有人都是件好事。”从“好事”到“问题”的落差刺激着外界神经的同时，似乎也预示着接下来FDA可能采取的行动。今年1月份花旗银行就解读，美国或许将基于同质化竞争、临床资源和定价体系等多方面因素考虑收紧对中国PD-1单抗的监管。春节刚过，理查德再次公开表示，国际多中心临床试验，而非单一国家数据，才是横跨全球药物开发和监管协调的桥梁。到2月8日晚FDA挂网肿瘤药物咨询委员会会议的首批材料，FDA针对单一国家临床数据收紧监管的信号被正式地释放了出来。恰恰是这场针对国产第一个出海PD-1的肿瘤药物咨询委员会会议，充当了FDA阐明“新规则”的发言场。对此，有人担忧，未来FDA针对中国药企的监管将越来越严，这将重创中国创新药的出海之路，前途一片黯淡。对于这种论调，FDA前审评专家王亚平只同意其中的一小部分。“FDA的监管比以前更加严格了，至少在癌症药物上比以前更加严格了，这点毋庸置疑。”在王亚平看来，任何药企初与FDA接触都需要磨合期，现在也正是大批中国创新药企业集中跟FDA接触的初级阶段，这次信达在肿瘤药物咨询委员会所遇到的挫折便是一次需要磨合期的体现。FDA

2022-02-1604 min

The Life Science Rundown Inspection Alternatives Are Driving More FDA Enforcement Actions: What It Means for IndustryProduct sampling and remote records requests accounted for most import alerts and drug GMP warning letters over FDA's fiscal year 2021. They may play a key role post-pandemic. As remote records reviews conducted during the pandemic accounted for a growing share of warning letters, experts have advised the industry to prepare for remote FDA oversight to continue even after routine site inspections resume and the pandemic recedes. The FDA, which historically relied solely on on-site inspections as a basis for drug adulteration warning letters, only based 28% of warning letters issued in the first 11 months of fiscal ye...

2022-02-1421 min

Food Safety Matters Ep. 112: Rogers, Mettler, Waller: FDA and Utah on an Integrated Workforce through Mutual RelianceErik Mettler is Assistant Commissioner for Partnerships and Policy within the Office of Regulatory Affairs (ORA) in the U.S. Food and Drug Administration. In this role, he serves as advisor to the Associate Commissioner for Regulatory Affairs on the full range of ORA's activities including partnerships, implementation of new laws and regulations, and overall strategic planning and prioritization. He is responsible for providing long-range strategic direction for ORA policies and programs including the implementation of the Food Safety Modernization Act. Michael Rogers is Assistant Commissioner for human and animal food (HAF) operations at FDA's ORA, focusing on inspection...

2022-02-0853 min

Global Medical Device Podcast powered by Greenlight Guru A Regulatory Gap Analysis of FDA's Systems & PoliciesWhat’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach.Some of the highlights of this episode include:Mike expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to...

2022-01-2753 min

Making MedTech Happen with RQM+RQM+ Live! #46 — Year-end Review and 2022 Outlook on FDA SubmissionsThis is the audio from RQM+ Live! #46, recorded 13 January, 2022. As we enter 2022, we'd like to reflect on what's happened over the past year in the world of FDA and medical devices. We'll be sharing our insights to how the Agency did in 2021 and a recap of the most important, cross-cutting regulatory changes. Additionally, we'll provide a forecast of what we can expect in 2022. This discussion will cover the following and more: Impact of COVID on FDA resources and submission timelines in 2021 Updates on breakthrough and new developments for innovative devices, such as the Safer Tech...

2022-01-1852 min

林氏璧孔醫師的日本旅遊情報站 211223 美國FDA給予輝瑞和默克新冠口服抗病毒藥物緊急使用授權 Novavax三針應可對抗Omicron小額贊助支持本節目： https://open.firstory.me/join/linshibi 這集podcast談談口服藥的新進展。 1.美國FDA分別於22日和23日批准輝瑞還有默克生產的新冠口服抗病毒藥物在家使用。但這都要經過醫師處方才能使用。 2.FDA批准輝瑞生產的新冠口服抗病毒藥物Paxlovid，須在症狀開始5天內服用，可用於在家治療高危險成人病患，以及12歲以上兒童。2085人臨床試驗顯示，高風險重症因子患者在服用默克口服藥後，住院和死亡情形可減少88%。最近實驗室數據顯示，該藥物也對Omicron變異株有效。 3.PAXLOVID是蛋白酶抑制劑的組合，一個劑量包含了兩顆新藥nirmatrelvir還有一顆老藥抗愛滋藥物低劑量ritonavir。加入Ritonavir的目的不是抗病毒效果，而是減緩新藥代謝的速度，從而增加新藥濃度。這是在抗愛滋藥物中已經經過長期使用的做法。一天隔12小時服用，療程五天，所以總共要吃30顆錠劑。 4.默克研發的口服藥Molnupiravir莫納皮拉韋也須在症狀開始5天內服用。1408人臨床試驗顯示，高風險重症因子患者在服用默克口服藥後，住院和死亡情形可減少3成。 5.莫納皮拉韋一個劑量要吃四顆膠囊，一天隔12小時服用，療程五天，所以總共要吃40顆膠囊。 6.不同於輝瑞，此藥只被批准於18歲以上成人使用。由於效果分別是近九成和三成，美國FDA在默克的新聞稿上寫著是在其他的治療無法獲得或是臨床上不適合使用的狀況下才使用，感覺是把它擺在第二線。 FDA強調，口服藥應該作為輔助，而非取代疫苗，疫苗仍是抗疫的首要手段。 04b解讀： 1.既生瑜，何生亮....出來了一個降低住院風險30%的，為何又來一個降低88%的....這兩個藥物抗病毒的機轉不同，即使一個產生抗藥性，另外一個還可以用。抗新冠的武器越多越好！選擇越多，可能價錢也比較有機會降低吧！ 2.是否輝瑞的藥效真的比默克好這麼多？未必。默克在第一次其中分析時安慰劑組有14.1%住院，輝瑞則是6.7%，後來全部分析完則分別是9.7%和6%。輝瑞效力差不多，默克則從50降到30%。我想應該是默克後來收案的案例已風險沒有這麼高的人居多，因此就稀釋掉了他的效果。而兩案各自僅是2085人和1408人分析的結果，樣本數其實沒有太多，還是有誤差的可能。接下來美國英國應該都會使用這兩個藥，會有真實世界的數據出來，讓我們拭目以待。 3.提醒大家，藥物和疫苗是相輔相成的，英國和美國監管單位強調，此藥不是要取代疫苗，疫苗還是很重要，提醒民眾要繼續打疫苗。 4.且對於一般人來說，至少在初期應該是無法隨意取得這些口服藥。首先這應該會是醫師處方，另外你必須要在有症狀五天內，再來還需要有容易重症的風險因子，才有機會服用這些口服藥。所以，如果你是50歲以下完全沒有任何慢性病，還是乖乖去打疫苗比較實際啦。 5.就算你符合用藥條件，如果有一天你得病了，你當然是希望可以的話盡量減低重症的風險呀！疫苗還有這兩個藥物，各自的作用機轉都不相同，疫苗可以降低約90%的重症住院風險，藥物再可以降30%和88%，這些是有機會可以疊加上去的效果。是我的話我當然都要。新冠口服藥物懶人包 https://linshibi.com/?p=39749 美批准輝瑞口服藥在家使用限12歲以上兒童、高危險成人病患 https://www.cna.com.tw/news/firstnews/202112230007.aspx FDA新聞稿 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19 美FDA批准默沙東口服藥增加COVID-19療法選項 https://www.cna.com.tw/news/firstnews/202112240005.aspx FDA新聞稿 https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-additional-oral-antiviral-treatment-covid-19-certain 英國採購COVID-19口服藥縮短確診者隔離時間 https://www.cna.com.tw/news/aopl/202112220355.aspx 對抗Omicron 數據顯示Novavax疫苗有效 https://www.cna.com.tw/news/aopl/202112230204.aspx 歡迎追蹤前台大感染科醫師。04b的發聲管道！我的電子名片 https://lit.link/linshibi 希望大家當我的種子教師，推廣正確的新冠衛教。科學防疫，不要只以恐懼防疫！歡迎贊助林氏璧孔醫師喝咖啡，讓我可以在這個紛亂的時代，繼續分享知識努力做正確新冠相關衛教。 https://open.firstory.me/join/linshibi

2021-12-2717 min

Global Medical Device Podcast powered by Greenlight Guru Why FDA is Prioritizing Clinical Decision Support Software & Why You Should CareAt the top of the FDA’s agenda for the next 12 months is clinical decision support (CDS) software — what is it, why now, and why should those in the medical device and other life science industries care about it?In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues with Vascular Sciences about the importance of CDS software.The FDA’s Clinical Decision Support Software Guidance was released in draft form in 2019 and is at the top of the FDA’s list of priorities to be finalized in 2022. Some of t...

2021-12-0231 min

林氏璧孔醫師的日本旅遊情報站 211018 美國FDA專家委員會全票通過莫德納嬌生疫苗加強針是否混打尚未有定論FDA10月14~15日兩場會議，歷時14小時，終於對莫德納和嬌生的加強針做出了結論！ 1.FDA專家諮詢委員會14日全票通過Moderna加強針，在65歲以上，18~64歲有重症因子者，還有職業風險者。在第二劑之後至少六個月後，給予半量的莫德納疫苗。 2.FDA專家委員會15日全票通過嬌生疫苗的加強針。這次沒有設限，在第一劑兩個月後皆可追加一劑；專家基本上認為，這個疫苗本來就應該打兩劑。雖然嬌生歷經時間過去沒有如同mRNA疫苗般看到明顯的保護力下降，但打第二劑可能讓保護力更提升。 3.至於針對NIH新臨床試驗第三劑混打不同疫苗的議題，沒有做出結論。因為該研究樣本數少，沒有隨機分派，追蹤時間短，問題還很多。 FDA advisory panel unanimously endorses Moderna’s Covid vaccine booster for some groups https://www.statnews.com/2021/10/14/fda-advisory-panel-unanimously-endorses-modernas-covid-vaccine-booster-for-some-groups/ FDA advisory panel votes 19-0 to endorse booster dose of J&J vaccine https://www.statnews.com/2021/10/15/fda-advisory-panel-votes-19-0-to-endorse-booster-dose-of-jj-vaccine/ 會前資料 https://www.fda.gov/media/152953/download https://www.fda.gov/media/152954/download 會議直播 https://youtu.be/QrMMuyDf8MM https://youtu.be/c-H40GrvWz4 今天的內容主要出自這裡，兩場會議的大致紀錄 Tracking the FDA advisory panel meeting on Moderna’s Covid vaccine booster https://www.statnews.com/2021/10/12/fda-scientists-moderna-covid-vaccine-booster/　 Follow the FDA advisory panel meeting on the J&J Covid vaccine booster https://www.statnews.com/2021/10/15/follow-the-fda-advisory-panel-meeting-on-the-jj-covid-vaccine-booster/ Delta變種病毒懶人包！ Podcast版 https://linshibi.pros.is/3pankg 部落格版 https://linshibi.com/?p=39717 各國分年齡的新冠致死率 https://linshibi.com/?p=35732 混打疫苗可行嗎？AZ混打輝瑞/BNT AZ混打莫德納等等 https://linshibi.com/?p=39613

2021-10-1941 min

Beyond Labels Premium Episode 7: The TRUTH About the FDA (In Their Own Words) with Joel & SinaJoel and Sina are known for revealing the truth about the FDA involvement with the decline in our food supply. Now they are tackling the other side of the FDA, which is involved in the approval of drugs and “pharma solutions.” Join them for a mind-blowing discussion that will leave you questioning the integrity of not only medications, “pharma solutions,” and the FDA, but of “science” itself. Take a stand against censorship and watch the video version on Rumble! - https://rumble.com/vnbivz-the-truth-about-the-fda-in-their-own-words-with-joel-and-sina.htmlLinks to References di...

2021-10-0740 min

Global Medical Device Podcast powered by Greenlight Guru When to Throw the Least Burdensome Flag on FDAWhat if you submit your 510(k), IDE, or other submission type to FDA only to get an additional information request (AI request)? What do you do for requests that seem overly burdensome? Thanks to a new FDA pilot program known as the Least Burdensome Flag, manufacturers now have a process and methodology they can deploy if and when this scenario arises.In this episode of the Global Medical Device Podcast host Jon Speer talks to guest Mike Drues, President of Vascular Sciences, about the ways in which manufacturers should approach responding to AI requests via the Least...

2021-10-0634 min

Making MedTech Happen with RQM+Live! #40 — When should we throw the least burdensome flag or appeal an FDA decision?This is the audio-only version of RQM+ Live! #40, originally recorded 30 September, 2021. This has been a very common question from device manufacturers since FDA issued guidance on “least burdensome” almost 20 years ago. FDA defines “least burdensome” to be the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time. Some manufacturers have strong opinions about pushing back on FDA with the argument of utilizing the least burdensome approach, while others are very hesitant to burn bridges. What’s the best approach to get the result...

2021-10-0138 min

2021-09-2423 min

Y博的科普园（新冠资讯分享）FDA 09/17 新冠增强针专家会议如何分析数据与风险收益讨论（0918科普小园新冠资讯分享下集）看一下在专家会上数据是如何被分析看待的。从药物审批看，最关键的数据一般是来自临床试验。辉瑞做的免疫桥接试验在正常情况下会是关键研究了。 FDA对专家们的提问也是说基于这个免疫桥接试验。但免疫桥接是否足以确认增强针的有效性安全性是被质疑的。为什么呢？因为这个仅有抗体数据。抗体数据对应多少有效性呢？这是未知的。然后这个免疫桥接试验是300多人，还全是18岁以上，老年人只有十几个，安全性足够吗？因为辉瑞申请的是16岁以上，现在年轻男性接种mRNA第二针后心肌炎风险更高。你试验全是18岁以上，现在怎么能说对16岁上都适用呢？实际上整个人数都有点少，也被专家们提到。所以最后FDA是要求专家们考虑增强针的整体数据，不拘泥于这个免疫桥接试验。这种临床试验不足的问题，也是申请为什么被改成EUA的重要因素。跳开免疫桥接试验，对增强针支持最有利的证据来自以色列的数据。但以色列看到的情况与美国差很远，比如美国这里重症防护仍然非常好，以色列有不少住院的是接种完疫苗的。如果说以色列接种早，美国不少人接种也早，Delta在两个国家都早就占主导了。美国即便有延迟，延迟能有多久呢？毕竟重症维持已经观察到很久了。因此以色列的数据未必具有适用性。此外，即便以色列的数据，也是基于60岁以上的人群。这也导致了为什么最后专家们普遍认为应该限制在老年人。辉瑞在被问道第三针安全性时经常指向以色列的安全性数据，但问题是mRNA疫苗的心肌炎风险是年轻人多，以色列现在打第三针的数据主要是60岁，没法借鉴。以色列的第三针有效，跟踪时间只有几周，带来了第三针到底维持多久的问题。如果是高危人群，那么你可以说这些人风险太大了，维持一天是一天，但要推广到所有人群，这种想法就不合适了。其它各种疫苗有效性的观察都没有太多可以支持增强针使用的。即将离职的一位FDA官员Philip Klaus在提问环节现场算了遍辉瑞与Kaiser合作的疫苗有效性跟踪，当场指出它们说的疫苗有效性下降不合理。为什么呢？他直接点了辉瑞的名，说我拿你们的数据算了一下，从第二针接种完算起，疫苗有效性是90以上的。你为什么能说后期有效性只有60不到了？你要是有几个月是60不到的有效性，你怎么维持整个时间段是90的。Kaiser的人被辉瑞拉出来解释了一下。这个FDA官员不依不饶，直接说你再来算一下你只打一针的有效性，那个就50多，你的意思是你第二针打了和白打一样吗？你第二针都没增强吗？这可能吗？当时绝对是高光时刻，基本属于把辉瑞与Kaiser的代表摁在地上摩擦了一遍。他其实提出了很重要的一点，很多这些观察性研究，涉及到复杂的统计建模，需要排除各种干扰因素。Kaiser的研究FDA都没有独立验证分析过的，辉瑞挑了很多这样的研究来支持增强针，有投机取巧之嫌。这也与另一位英国专家介绍的疫苗有效性观察部分有呼应，即跟踪疫苗有效性并不容易，很多研究都有各种bias，要仔细鉴别。这也适用于以色列的数据。虽然FDA强烈建议与会者参考以色列数据，但太多差异与疑问没法解决，这种劝说显然不具备说服力。 FDA的数据分析也提到了很多分析的局限性。比如辉瑞三期临床试验揭盲后的安慰剂组与疫苗组交叉，分析接种5个月与10个月差异。在三期临床试验阶段疫苗接种组60%以上人也是跟踪了4个月以上，感染率是每1000人天，对应12.6例。但在揭盲后的交叉试验里，接种短于四个月的，每1000人天对应有43例，远高于三期临床试验里看到的风险。5个月那批对应的是51， 10个月对应73。可见除了时间，其它因素可能也会影响感染风险，甚至影响更大。所以这些分析都要考虑其可能的局限性上述只是整个会议分析的一部分。但从这些可以看出，虽然可以找出一些支持增强针的证据，但充分性是非常有限的。反倒对于美国来说，大量的证据显示增强针还不是一个普遍必要。最后再说一些科学原理争论与收益风险分析。一个是为什么观察到疫苗有效性下降。这个可能有两个因素，一个是时间，另一个是突变。这两个现在是没法区分的。很有意思的是辉瑞在想办法往时间上靠。比如Kaiser的研究为什么它拿出来当最主要证据，因为这个研究发现无论是不是Delta，有效性随时间都下降了，而且相对非Delta，Delta没有导致更多下降。为什么辉瑞要强调时间因素？因为如果是突变引发的改变，一个自然的问题是你为什么不去做个针对突变的疫苗。但这样它现在卖不了增强针了啊。所以要往时间靠。但它往时间靠也引发了问题。一个是大家不买账。以色列的专家还特别强调了Delta影响很大，不是光是时间问题。另外一个是如果你说是时间影响的，增强针后也会有时间问题啊。你增强能持续的时间是多久？这个你回答不了。你观察到的抗体增强，如果要考虑时间，还有多少意义？所以最后这个提法没得到太多认同。另一个是增强针的机理问题。第三针数据主要是抗体，一个问题是除了抗体还有什么。比如记忆细胞，细胞免疫。不少专家都提出第三针对这些有什么影响，以及这些对重症防护的影响。辉瑞没有这方面的数据，它的理论是抗体更关键，特别是对感染防护。辉瑞的准备有点仓促。因为明显第三针主要以重症防护为标准，而从原理上来说，免疫记忆与细胞免疫对重症能起很好的作用，所以强调抗体作用有偏颇。专家们其实想知道的是第三针能不能完善免疫记忆。现在一些研究显示第二针免疫记忆非常完全，这就让第三针除了抗体外的收益可疑。然后辉瑞就说疫苗两针后记忆细胞非常好，被专家抓出来说，你说记忆反应很好，但这不就和你说的疫苗有效时间短矛盾了。在如此依赖抗体的情况下，专家也提出了你有任何证据指出抗体低到什么程度，保护有问题了吗？结果辉瑞说没有。特别提到三期试验里突破性感染没看到与抗体有关。这个和Moderna的发现不一样，有点奇怪。你那么强调抗体，至少也在这方面准备稍微充分一些。以色列之前有医护突破感染研究显示还是有一定关联的。强调抗体也带来了抗体维持多久的问题，因为抗体肯定会下降，你又没数据说第三针抗体维持多久，都有点一问三不知了。这些也反应出科学界对增强针希望有更好的机理研究。辉瑞的行为有点只做到最低标准来碰运气的感觉。现在疫苗最重要的作用，对美国来说是防护重症，这点其实对其它绝大多数国家也是一样的。在大量的数据表面已有疫苗接种在美国仍然防护重症很好，甚至基本没有变化时，增强针的收益是难以明确的。这一点被多位专家提及。而风险一块，特别是年轻人的心肌炎风险，又是未知的，这是专家们大比例反对全民增强针的主要原因。增强针的收益风险考虑不能是打增强针与没打疫苗的比，而是与打了疫苗但没打增强针的比。辉瑞在正式投票前看很多专家提到年轻人的心肌炎，说虽然不知道打增强针的心肌炎风险，但从打疫苗后的心肌炎看，风险远不如得新冠来的大，对所有年龄都是收益大于风险。这就是偷换概念，立刻被CDC的专家纠正，因为对所有年龄收益大于风险，是基于与没打疫苗比。增强针的收益风险，要考虑的是，对于一个已经打过疫苗的人，再打一针，第三针新的心肌炎风险与增强针带来的进一步的防护重症或感染的收益，这二者是怎么比的。对于一个已经打过疫苗的人，特别是年轻人，增强针进一步带来的收益很可能是有限的，因为前两针已经可以防护很好了，所以这时候很难说收益一定大于风险。期望值也很关键。美国的主要转播来自于未接种疫苗的人，增强针是根本不会碰这一块的。有几位专家提到了，施打增强针，对整个疫情的帮助是会非常有限的，我们要传达的最主要信息还是大家尽快接种疫苗。一位专家也问了CDC，如果把现有疫苗覆盖率提高了，我们是不是就能控制疫情了，为什么这么问，因为如果疫苗覆盖率提高还解决不了问题，那么增强针才值得讨论，否则你不就是再舍近求远吗？CDC的专家比较婉转，没有做太多猜测，但提到了现在的疫苗接种率是不行的，主要传播还在没接种的人，需要提高接种率，而且疫苗可能也没法单独解决问题，还是会需要戴口罩与社交距离。从这些来回反复的分析讨论也能看出来，增强针还缺乏强有力的证据，而且实际作用对于美国的现状，甚至对绝大多数国家而言，作用也可能非常有限。在这种情况下，限制在高危人群，这个投票结果是更合理的选择。浪费太多时间在试图推广增强针上是本末倒置。像FDA的专家会，FDA的Peter Marks专门提到今天只考虑增强针的科学性，不考虑全球疫苗供应，具体实施难度等。但考虑科学性就要考虑风险收益，即便不考虑全球情况，单独看美国，甚至再缩小到FDA的优先级别。那么增强针，特别是辉瑞的增强针都应该是排不上号的。为什么？因为现在还有12岁以下的小孩没有疫苗，这是不少人没有疫苗可打，应该是FDA首要关注的。然后12-17岁美国仍然只有辉瑞，Moderna的还没批，增加可选的疫苗也是有意义的。再然后，完全批准的只有辉瑞，一样，增加可选择性，很多人万一就是不喜欢辉瑞呢？所以Moderna的完全审批也应该重于辉瑞的增强针。即便上面这些都解决了，排到增强针了，一些研究显示强生的保护更弱一些，它还就是一针，所以强生的增强针排序应该要优于或至少不次于辉瑞的。现在我们浪费太多时间与精力在辉瑞的问题上面，是属于被别人牵着鼻子走，是很愚蠢的。希望这次非常明确的投票结果，可以明确增强针的必要标准，也可以再度明确防疫的轻重缓急问题，让美国这里防疫的重心再度回到正轨上来。

2021-09-1817 min

Y博的科普园（新冠资讯分享）FDA 09/17 新冠增强针专家会议的背景意义与讨论数据汇总（0918科普小园新冠资讯分享上集）背景与结果 9月17号FDA召开了关于辉瑞疫苗增强针也就是第三针的专家会议。这是增强针批准过程中非常关键的一步，也是非常重要的讨论。美国如果要推广增强针，不是说随便哪个人跑出来说明天大家撸起袖子打第三针就开始的。有几个很重要的步骤。第一个步骤是FDA要批准，当然批准之前需要药企把相关的数据递交上去。比如辉瑞的说法是我递交了sBLA。BLA是一个生物制剂药品的FDA审核申请，比如新冠疫苗要作为一个普通疫苗正式上市，那你要递交BLA。辉瑞之前的BLA批准了，它的新冠疫苗已经是正式上市的疫苗，不再是紧急使用授权的疫苗。对于已经上市的药物，有时候你要改剂量，改疗程，这时候药厂递交的就是sBLA。辉瑞这次是申请用第三针作为增强针，所以它递交了sBLA。药企递交之后，FDA会做自己的评估，然后要给答复，是通过还是不通过。通不通过这个是FDA做决定的。但有些时候，有效药物递交上来的数据，FDA认为需要再参考外部专家的意见，就会召开这样的专家会议。一般来说，会议出现的背景是数据让FDA认为需要更多讨论，特别是让独立的专家们提供一些建议与看法，算是集思广益。如果数据非常好或非常差，那一般是不会开，因为没太大必要，不影响最后决定。增强针开专家会议，数据方面想参考外部意见，应该是考量之一。之前增强针的各种数据，特别是关于现在需不需要增强针方面的，疫苗有效性有没有下降，不同的研究有很多不一致，所以召集专家会议可以对这些数据做个讨论分析。另外一个非常重要的因素，甚至可能是更重要的一点，是新冠疫苗的一切变化都非常引人注目。美国增强针的提议在过去一个月不仅是引发大量关注，还引发了很多争议。FDA是负责药品审核监管的部门，它必须要维持自己决策的科学性、公正性。召开一个公开的专家会议，可以让FDA专注于讨论增强针的科学性问题。也可以让公众确信，无论最后FDA做出的决定是什么，这是基于科学数据，而不是其它因素。所以周五的专家会议不决定增强针是否通过。审核增强针的决定权还是在FDA。但一般来说，FDA会尊重专家会议的意见。然后，FDA通过只是增强针的一个步骤，还有一步是CDC的ACIP要同意开始使用。从某种程度上说，增强针的问题上，CDC的ACIP的作用甚至更大，因为它不仅是确认什么时候开始使用增强针，还负责确认谁需要使用。因此，增强针的问题不是FDA专家会结束就结束了，甚至不是FDA批准就批准了。而CDC的ACIP计划在9月22-23号开会，所以很可能至少要到那个时候才会有基本的结论。以上是一些增强针审批流程的背景。那在这一个背景下，专家会议的最后结果是什么呢？专家们一致投票同意在65岁以上与高危人群的辉瑞接种人群中使用增强针（间隔至少6个月）。这是修改过适用人群后的投票结果。最初的投票问题是所有16岁以上人群，以绝对多数专家反对而告终。其实在投票前的讨论中，很多专家都表示了对这个非常宽广的适用人群非常不感冒。所以在初次投票前就提出可以如何修改问题，让专家们得出一个比较一致的推荐。此外，这个增强针被修改成紧急使用授权，不再是辉瑞之前申请正常上市的sBLA。这点也反应了会议上对第三针数据方面的疑虑。总的来说，最后的结果比较合理，也更符合现在的数据支持。当然FDA不一定要遵从专家投票结果，可以做改动。但应该不会有大动，至少不至于改回到最开始提出的16岁以上全批。除了FDA接下来要正式批准外，CDC ACIP还要做推荐。后者现在定了22-23号开会。这已经确认美国政府提出的20号打增强针计划不可能按期实施。可以预计接下来几天，美国政府的相关人员将继续被迫解释为什么当初定20号是对的以及为什么现在20号不行了也是对的。具体数据再来看看在这个会议里分析到的主要数据。最近增强针的消息特别多，一会就有一个研究说疫苗有效性出现什么变化了，需要增强针了。很多国家也批准了增强针，但我们非常缺乏一个全面讨论增强针数据、政策的公开过程。从这点上来说，FDA召开了这样一个专家会议，本身就非常有意义。这个会议投票结果可能只会直接影响美国一个国家的增强针政策。但里面的很多数据、信息，对全世界关心新冠增强针的人，都有帮助。这次会议中涉及的数据资料有四个部分。首先是CDC流行病学数据，包括它总结的一些疫苗有效性跟踪数据。这个主要是针对美国这里的，也是整个讨论的基础。现在讨论增强针，很多人很喜欢向前看，喜欢说某个国家在我们前面，我们就要看那个国家的数据。这么说一定道理，但要注意一点，你最后要解决的问题是眼下的，是你自己国家地区的，别的国家或者某个国家，不一定能代表你要遇到的情况。像美国讨论增强针，基础应该是美国这里疫情，美国现在的疫苗有效性维持状况。所以CDC的流行病学数据，包括疫情状况与疫苗有效性跟踪，是非常重要的。从这些数据来看，美国的疫情主要还是由未接种疫苗的人在传播病毒。然后疫苗防护轻症或无症状感染的有效性在降低，具体降低多少不同研究不一样。但防护重症的有效性仍然维持在很高的水平，甚至可以说，现在没有充足甚至是有一点一致性的证据说，疫苗防护重症的作用在明显下滑。从CDC的数据分析来看，增强针在美国不是一个很急迫的事情，特别是要针对所有人群的增强针，那么必要性就更低了。第二个资料是来自一位英国的专家。他也是在周一柳叶刀上反对增强针的意见论文的作者之一。还有两位作者是FDA即将离职的官员。那篇文章收集了很多真实世界研究，发现大多数研究显示疫苗有效性仍然很好，不需要增强针。但会议上只是简略带过了柳叶刀上的分析，他讲的重点不是分析疫苗有效性或增强针的研究结果，他是在讨论分析真实世界里疫苗有效性，需要注意什么。疫苗有效性最准确的研究肯定是三期临床试验，到真实世界追踪疫苗有效性，会有各种干扰因素，造成你的结果不准。这位专家没有讲太多数据，但他提供了非常重要的一个背景思考，就是你看疫苗有效性下降或增强针效果很好，这些数据，如果是来自真实世界分析，一定要考虑有什么干扰因素。第三个是以色列的数据。这是以色列的研究人员与卫生官员亲自来讲的。主要是周三发表在新英格兰医学杂志上的以色列增强针数据。根据以色列的研究，打了增强针后，感染的风险下降了10倍，对重症也有显著提高。如果以他们之前的研究，认为辉瑞现在的有效性下降到50%，这种风险下降对应的是有效性提高到95%，与临床试验时的结果类似。重症风险也下降了10倍，如果之前防重症有效性时80%，可以增强到97%。第四部分是辉瑞和FDA分别分析辉瑞增强针的相关数据。这里面很大一部分是增强针的免疫桥接。也就是辉瑞300多人的增强针免疫反应与安全性数据。这300多人绝大多是是18-55岁的人，有十几个是60岁以上的老年人。从抗体反应上来看，打完第三针后抗体确实拉升到比第二针后高峰还高的程度。从安全性上看，打完后的常见不良反应与第二针后的类似。有一个腋下淋巴结肿大的比例有增加。这里可能有报告方式不同的影响。因为辉瑞三期临床试验里淋巴结肿大不是调查问卷里的，是受试者自己报告。这就可能有漏报，像它的统计是0.4%的人有，人家Moderna是直接提问的，比例是16%。现在增强针提到到5%了，不一定是真的比例提高10倍多，很可能是现在把这个作为常见不良反应纳入到问卷调查里去了。总的来说这些研究显示增强针确实可以增加抗体，常见不良反应方面也是可以接受的。可以说是符合FDA之前提供的增强针免疫桥接实验指导思想。但对于增强针，辉瑞自己也很清楚，很重要的问题是现在是不是需要的时候。所以它也提供了很多流行病学数据，有一定的挑选成分，为什么，因为它挑了一系列显示疫苗有效性虽时间出现下降的研究。除了以色列的研究，它另外着重强调了和Kaiser合作的一项研究，显示在美国，随着时间的推移，疫苗有效性出现了下滑，到了50-60%左右。要注意的是，即便是这项辉瑞作为增强针非常必要的最关键证据，里面显示疫苗对重症的保护仍然非常好。还有一项研究是在FDA要求下做的。辉瑞之前的三期临床试验，之前安慰剂组的人不是后来打了疫苗了吗？那么相对最开始疫苗组的人，这些安慰剂组的人不就是晚接种疫苗吗？这样在这个三期临床试验里，就有了一队平均接种时间4.7个月的人，与另一队平均接种9.8个月的人。FDA就说，你去看看，这两组人，从7月1号到8月31号，感染率有区别吗？辉瑞去分析了一下，说相对接种9.8个月的人，4.7个月的人有效性有26%。感染风险确实是接种9.8个月的人更高。它还提出一个假设，如果你5个月时有效性是70%，那么10个月时就可能下降到60%以下了。不过FDA最这个研究做了更详细的解释。所谓的5个月对10个月有26%有效性，应对的是5个月对10个月，相对感染风险是73%。如果你假设10个月有效性是80%，那么5个月有效性是86。之前辉瑞三期临床试验，说每两个月有效性下降6%，4-6个月的时候有效性只有84了。这倒是对上了，但反应出来的问题就是，5个月与10个月之间的实际差异真的很小，所谓的随时间有效性下降，程度并非辉瑞宣传的那么夸张。从这些数据来看来看，增强针的必要性是个主要争议点。大部分研究指向的是防感染或轻症有一定下降，程度还不明确，重症防护仍然非常好。增强针的有效性比较明确的是可以增加抗体，安全性在常见不良反应上与第二针类似。但罕见不良反应如心肌炎并不确定。然后以色列的保护作用现在体现在60岁以上的人。增强针的批准问题，仍然会集中在必要性，以及是否有足够的有效性安全性数据支持增强针利大于弊。

2021-09-1814 min

Pelos Ouvidos da FDA Episódio 13 - Professor Alberto Jorge - Magistratura, Docência e Ciências CriminaisNo décimo terceiro episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Alberto Jorge para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-09-181h 13

Life with Tina Vaccine mandates: The FDA is deceiving Americans. What you need to know right now!Hi friends, unfortunately the FDA & our government is deceiving the American people with this "FDA approved" vaccine. If you or someone you know is faced with this mandate, I highly recommend that you listen and share this podcast episode. The current Pfizer BioNTech vaccine that is being administered is NOT, I repeat, is NOT as of the date of this episode approved by the FDA. The only Covid-19 FDA approved vaccine is called "Comirnaty" and it isn't even available in the US at this point for distribution. See FDA letters linked below. As promised, here are the...

2021-09-0356 min

Pelos Ouvidos da FDA Episódio 12 - Egressa Lívia Lemos - Direito Internacional, Refugiados e PesquisaNo décimo segundo episódio do podcast Pelos Ouvidos da FDA, convidamos a egressa da Faculdade de Direito de Alagoas Lívia Lemos para falar sobre seus anos no curso e a contribuição deste para a sua vida. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-08-311h 00

Merkaba Chakras Podcast PART 1 - FDA Pushes Failed CV-19 EUAs, Hides Successful Repurposed DrugsYou can watch the video presentation here: https://rokfin.com/MerkabaChakras https://www.bitchute.com/video/0Fv4iYZwAmIu/ https://www.brighteon.com/2620ec65-1ef8-45de-9225-dc6220988e78 https://rumble.com/vlfkaf-fda-authorizes-failed-cv-19-euas-hides-successful-repurposed-drugs.html Resources for the presentation. HQC used successfully by thousands of doctors on severe CV-19 hospitalizations. https://bit.ly/3k9h7P1 FDA revoked EUA of HQC in March, 2020. https://www.fda.gov/media/136534/download April, 2020 Remdesivir trials finished. FDA approves in...

2021-08-311h 55

Pelos Ouvidos da FDA Episódio 11 - Professor Paulo Cordeiro - Docência, Magistratura e JustiçaNo décimo primeiro episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Paulo Cordeiro para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-08-2649 min

The Life Science Rundown FDA's Domestic Biopharma Inspections Return to NormalFor the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, according to FDA acting commissioner Janet Woodcock. “I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said. The return to normalcy will be welcomed by industry, which has grappled with a growing backlog of mostly surveillance inspections, although some of those delayed inspections have also delayed the approval of new drugs. According to a report from...

2021-08-0508 min

Pelos Ouvidos da FDA Episódio 10 - Professora Lavínia Cavalcanti - Mediação, Cultura da Paz e ComunicaçãoNo retorno do podcast Pelos Ouvidos da FDA, convidamos, no décimo episódio, a professora Lavínia Cavalcanti para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-07-311h 23

Pelos Ouvidos da FDA Episódio 9 - Professor Marcos Bernardes de Mello - Tradição, Docência e AdvocaciaNo nono episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Marcos Bernardes de Mello para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia Observação: Esse episódio foi gravado no dia 21/05/2021.

2021-07-231h 22

CORONAVIRUS. COVID-19 96-TRATAMIENTOS ESPECÍFICOS APROBADOS Y AUTORIZADOS PARA USO DE EMERGENCIA POR LA FDA. EN EL MANEJO DE PACIENTES CON COVID-19. ACTUALIZACIÓN A LA FECHA.Hasta el día de hoy para el tratamiento específico de pacientes con COVID-19, con acción directa contra el virus SARS CoV-2. Estamos usando medicamentos antivirales, anticuerpos monoclonales e inhibidores de proteínas. En este episodio describiremos 2 tipos autorizados por la administración de Drogas y Alimentos de los EE. UU. (FDA). Por un lado, los que son aprobados y por otro lado los que son solo autorizados para uso de emergencia. Además, cuales son para pacientes hospitalizados y los que son para los pacientes no hospitalizados. Tratamientos aprobados y autorizados por las FDA. ...

2021-07-1110 min

2021-07-0410 min

The Life Science Rundown Quality Management Review: Benchmarking Quantitatively!The FDA Group’s CEO, Nick Capman, sits down with Tobias Kuners of Koenders, Managing Consultant at Tob Management, to discuss his integrated approach to implementing and interpreting qualitative and quantitative metrics in the GMP and non-GMP sides of a life science business. Read his full column in Pharmaceutical Online: https://www.pharmaceuticalonline.com/doc/quality-management-review-benchmarking-quantitatively-0001Tobias has worked with Biogen, Ipsen, Thermo Fisher, Kite Pharma, and Danone, among other companies, gaining hands-on experience in engineering services, equipment qualification, maintenance, supply chain, warehousing, and distribution. He has led the design, engineering, and construction of multiple facilities to me...

2021-07-0226 min

Health Equity Forum A conversation with the FDA Chief Scientist: Learn about the Emergency Use Authorization (EUA) ProcessIn this episode, RADM Araojo discusses FDA’s Emergency Use Authorization process with RADM Denise Hinton, FDA’s Chief Scientist.

2021-06-0810 min

The Life Science Rundown Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, GAO's Director of Health CareThe FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a pandemic-induced inspection backlog, and what measures the agency may take to address it.Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in public poli...

2021-06-0331 min

Pelos Ouvidos da FDA Episódio 8 - Técnica Marluce Cunha - Legado e DesafiosNo oitavo episódio do podcast Pelos Ouvidos da FDA, convidamos a sra. Marluce Cunha, membra do corpo técnico da Faculdade de Direito de Alagoas, para uma conversa acerca dos seus anos na FDA. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-2153 min

Pelos Ouvidos da FDA Episódio 7 - Técnica Gilda Monteiro e o setor administrativo da FDANo sétimo episódio do podcast Pelos Ouvidos da FDA, convidamos a membra do corpo técnico Gilda Monteiro para falar acerca dos seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-2014 min

Pelos Ouvidos da FDA Episódio 6 - Professor Beclaute Oliveira - Arte, Filosofia e DireitoNo sexto episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Beclaute Oliveira para falar sobre seus anos como aluno e como docente da Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-192h 05

Pelos Ouvidos da FDA Episódio 5 - Professor George Sarmento - Direitos Humanos, Constituição e EducaçãoNo quinto episódio do podcast Pelos Ouvidos da FDA, convidamos o professor George Sarmento, atual coordenador do curso de Direito da Universidade Federal de Alagoas, para falar sobre seus anos como aluno, professor e sobre o início de seu trabalho na coordenação do curso. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-181h 49

Pelos Ouvidos da FDA Episódio 4 - Professora Juliana Jota - Meio Ambiente, Docência e PesquisaNo quarto episódio do podcast Pelos Ouvidos da FDA, convidamos a professora Juliana Jota para falar sobre seus anos como docente da Faculdade de Direito de Alagoas, além do seu período como coordenadora do curso. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-182h 02

Pelos Ouvidos da FDA Episódio 3 - Professor Welton Roberto - Docência, Advocacia e Ciências CriminaisNo terceiro episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Welton Roberto para falar sobre seus anos como docente da Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-131h 21

The Life Science Rundown Addressing FDA's Inspection Backlog with Mary Denigan-Macauley, Director of Health Care, GAOThe FDA Group’s CEO, Nick Capman, sits down with Mary Denigan-Macauley, Director of Health Care in the Government Accountability Office (GAO) to understand the situation the FDA finds itself in with respect to a pandemic-induced inspection backlog, and what measures the agency may take to address it. Mary joined GAO in 2001, managing a diverse portfolio related to science and animal health for GAO’s Natural Resource and Environment team. This work covered cross-cutting topics such as foreign animal diseases, antibiotic resistance, food safety, and emergency preparedness. Prior to joining GAO, Mary taught various courses in publ...

2021-05-0731 min

Pelos Ouvidos da FDA Episódio 2 - Professor Hugo Leonardo - Criminologia, História e PesquisaNo segundo episódio do podcast Pelos Ouvidos da FDA, convidamos o professor Hugo Leonardo para falar sobre seus anos na Faculdade de Direito de Alagoas. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Wagner Victor Correia

2021-05-031h 34

Pelos Ouvidos da FDA Episódio 1 - Professora Elaine Pimentel - Feminismo, Cárcere e RepresentatividadeNo primeiro episódio do podcast Pelos Ouvidos da FDA, produzido pelo grupo responsável pelo resgate histórico dos docentes na década de 2011 - 2021, convidamos a professora e diretora do curso de Direito da Universidade Federal de Alagoas, Elaine Pimentel. Apresentadora: Morgana Beltrão Perguntas: Kalênia Laura Layla Duarte Mariana Miranda Wagner Victor Correia

2021-05-012h 11

The Vaccine Challenge US FDA on COVID19 vaccine approval at record speedThis episode of The Vaccine Challenge is hosted by Priyanka Asera and features Peter Marks, Director, Director Center for Biologics Evaluation and Research, Food & Drugs Administration.We’ve asked Peter some really important questions around how FDA has been giving vaccine approval at record speed, why the embargo on vaccine raw materials to rest of the world, their relationship with other regulatory bodies, and whether there will be permanent changes in how the FDA functions, development and approval timelines given the speed at which these vaccines have come to market.If you want to hear mo...

2021-04-3021 min

The Life Science Rundown FDA's Fraudulent Products Task Force and Operation Quack Hack Battle COVID Vaccine ScamsThe FDA Group’s CEO, Nick Capman, discusses the federal effort to thwart COVID-19 vaccine scams.Read the full article on FDA.gov here.Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn more and get the conversation started: www.thefdagroup.com.

2021-03-0908 min

The Life Science Rundown What to Expect for the FDA's Regulation of Medical Devices & Digital Health Under the Biden AdministrationThe FDA Group’s CEO, Nick Capman, breaks down the key points in a recent Morgan Lewis article laying out what to expect for the FDA's regulation of medical devices and digital health under the Biden administration. Read the full Morgan Lewis piece here.Need RA/QA/Clinical project or resourcing support? The FDA Group helps thousands of life science organizations rapidly access the industry's best consultants, contractors, and candidates. Our resources assist in every stage of the product lifecycle, from clinical development to commercialization, with a focus in Quality Assurance, Regulatory Affairs, and Clinical Operations. Learn mo...

2021-01-2808 min

The Life Science Rundown Clinical Outsourcing & Insourcing: Selecting the Right Model or MixThe FDA Group’s CEO, Nick Capman, sits down with Mark Shapiro, a Partner with biopharmaceutical consulting firm Pharma Initiatives, to discuss outsourcing and insourcing models in the current clinical R&D environment, and what to consider when selecting the right model or mix of models for a project.Download the corresponding white paper and put these insights into practice: A Modern Guide to Clinical Operations Resourcing.Mark is widely recognized as an expert on the business of clinical research and is frequently quoted in the press, including Outsourcing Pharma, PharmaVoice, and CenterWatch. His comments ha...

2021-01-1232 min

The Life Science Rundown What RA/QA/Clinical Leaders Should Expect From the FDA in 2021The FDA Group’s CEO, Nick Capman, sits down with Ben Locwin, Senior Consultant for Public Health Outreach at the CDC, and Executive Advisor for Valeocon Management Consulting, to discuss what life science leaders should expect from the FDA in 2021 as it pertains to quality system management, regulatory approvals, GxP compliance, and more.Ben has extensive experience working with the FDA and international regulatory officials. His project work includes Pre-IND, NDA, Ph1-3, and marketed/post-market drug products, as well as PMA and 510(k) medical devices. Ben has trained FDA inspectors within their headquarters and has participated in...

2020-12-1643 min

The Life Science Rundown Inside FDA Pre-Approval Inspections with Former FDA Investigator, Christopher SmithThe FDA Group’s CEO, Nick Capman, sits down with Former FDA Investigator, Christopher Smith to dive deep into FDA Pre-Approval Inspections (PAIs). Chris has more than 35 years of experience having held senior positions at the FDA, large and small pharmaceutical companies, and contract research organizations. Learn how PAIs are planned and conducted, how to prepare for them, and where to go to find helpful resources your team can utilize. Need expert help with PAI preparation? Connect with The FDA Group to schedule a mock PAI or discuss other quality and compliance support. Learn more about our GMP...

2020-11-1251 min

The Life Science Rundown A Look at FDA's Pandemic Inspections Q&A GuidanceThe FDA Group’s CEO, Nick Capman, breaks down the FDA’s Q&A guidance on drug and biologic inspections during the pandemic, pointing out the important takeaways manufacturers should consider and prepare for. Read our blog post for a written breakdown of the key takeaways. We've also written on FDA's more recent guidance outlining its expectations for resuming normal manufacturing operations during the pandemic. Read that post here. Need expert quality system remediation assistance? Learn more and get in touch.Links and Resources: Blog Post: 7 Key Takeaways from FDA's Pandemic Inspections FAQ Guidance Blog Post: Key Tak...

2020-11-1204 min

Regenerative Medicine News 8. I Analyzed The FDA Approval Process And Here's Why I'm Pissed (References Included)"That's great but is it FDA Approved?" You may have asked yourself this a few times before. But what Austin Wolff reveals in this episode is that "FDA Approval" is a bit more complex than you think, and why you should re-think what FDA Approval actually means for your safety. References included in the Show Notes below. Transform Your Body And Change Your Life With Biotech: https://www.ModernBiotechRadio.com Learn How The Rocket Can Upgrade Your Sex Life: https://getmyrocket.com ...

2020-05-0439 min $Sheppard Mullin\'s Nota Bene$

Sheppard Mullin's Nota Bene Shifting Regulatory Landscapes at the FDA: Cannabis, Vaping and Intelligent Medical Devices with Allison Fulton2019 ushered in numerous changes and new initiatives at the U.S. Food and Drug Administration (FDA). From the increasing popularity of cannabis use to the rapidly evolving nature of artificial intelligence in medical devices, we're reflecting on some of the initiatives the FDA tackled in 2019 and exploring what lies ahead for the agency in 2020. Joining me for this conversation is Allison Fulton. Allison is a partner in the Life Sciences and FDA team and is based in Sheppard Mullin's Washington, D.C. office. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic...

2020-03-0452 min

The Healthcare Policy Podcast ® Produced by David Introcaso 190th Podcast Interview: the FDA's Captain Valerie Jensen Discusses Remedying the Drug Shortage Problem (November 20th)Listen NowOn October 31st, the FDA released the agency's Congressionally-mandated report titled, “Drug Shortages: Root Causes and Potential Solutions.” The 124-pg report found drug shortages are increasing, persistent, i.e., the duration longer, with both the intensity and public health impact high. These shortages can, the FDA found, “have a devastating effect,” by prolonging patient suffering, contributing to disease progression & increased morbidity. Concerning root causes, the FDA found market consolidation has caused current contracting practices to constitute in sum a “race to the bottom.” The FDA also found the market also fails to recognize or reward manufacturers for...

2019-11-2127 min

EDC Weekly Commentary by Peter G. Hall (Audio)Ep. 074 – How to Get a Job at the FDA with Steve Gendel, Vice President, Division Food Allergens at IEH Laboratorieshttp://myfoodjobrocks.com/074Steven Steve Gendel has worked in the FDA for 25 years and this guy has had an amazing career doing so. He’s been involved in the latest and greatest technologies ranging from early stage GMOs, Food Allergen Labeling and Consumer Protection Act, and of course, our favorite one right now, FSMA. The best part of this episode is the very practical and real advice he give son how to get a job at the FDA. Of course, it’s a special mix of fiscal year luck, and who you know. He tells you the best places to meet p...

2017-07-1045 min

My Food Job Rocks!Ep. 074 – How to Get a Job at the FDA with Steve Gendel, Vice President, Division Food Allergens at IEH LaboratoriesSteve Gendel has worked in the FDA for 25 years and this guy has had an amazing career doing so. He’s been involved in the latest and greatest technologies ranging from early stage GMOs, Food Allergen Labeling and Consumer Protection Act, and of course, our favorite one right now, FSMA. The best part of this episode is the very practical and real advice he give son how to get a job at the FDA. Of course, it’s a special mix of fiscal year luck, and who you know. He tells you the best places to mee...

2017-07-1045 min