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头条之外阿富汗老兵的悲剧，委内瑞拉的战争疑云，FDA领导危机 EP12这一期的关键词，是战争、迷雾与真相你会听到【🎙️时间轴】00:25 华盛顿枪声背后的漫长阿富汗战争阴影11月26日，这是美国今年感恩节的前一天，这在美国，本应该是一个人人无心上班，盼着立刻回家和家人们团圆的日子。但就在这一天，美国首府华盛顿白宫附近的枪声，打破了节日气氛。阿富汗籍男子拉坎瓦尔突然开枪攻击两名正在巡逻的国民警卫队士兵。其中一名士兵，20岁的萨拉·贝克斯特罗姆已经因伤势过重不治身亡。另一名国民警卫队成员，24岁的安德鲁·沃尔夫，则伤势“严重”。在事件发生后，特朗普立刻将所有责任推到拜登时期接受难民上，认为让难民进入美国就是带来混乱。但是随后几天陆续披露出来的信息，却让这期枪击案的动机披上更多迷雾，也似乎向我们展示了一个巨大的悲剧。11月26日在美国首府华盛顿开枪袭击两名国民警卫队士兵的嫌犯卡坎瓦尔曾在阿富汗为美军作战长达十年，其所在部队Zero Units由CIA资助、训练、指挥，为美军在阿富汗最信任的部队，据称其成员几乎人人都有家人死于塔利班之手。由于该部队特殊性，被认为会是塔利班掌权后的首选报复目标，因此2021年美军撤离阿富汗时就成为最优先撤离的阿富汗难民08:40 加勒比海上空的战争迷雾在加勒比海，特朗普政府似乎正在酝酿着一场更为诡异的战争：动用军队，以清剿毒贩，终止毒品输入美国为由，攻击委内瑞拉的一些船只。目前，美国最大的航母，吉拉德福特号已经部署到了加勒比海，参与所谓的攻击贩毒船只的军事行动。同时，所有在加勒比海的美军，即将到来的圣诞节假期都被取消了。11月29日时，特朗普更是宣称委内瑞拉的领空处于关闭状态，即警告外国航班不要前往或经过委内瑞拉。剑拔弩张，但美国这一切行为的合法性却在最近遇到了更大质疑。特朗普从第一个任期起就一直致力于推翻委内瑞拉的马杜罗政权，近期把对马杜罗的悬赏增加到5000万美元17:31FDA核心部门主管再度刷新最短任期记录12月2日，美国FDA最核心的部门，药物评估与研究中心（CDER），其主任Richard Pazdur宣布将在月底离职退休。Pazdur在11月11日才开始主管CDER，接替11月2日突然辞职的George Tidmarsh。仅仅一个月，CDER将再度陷入群龙无首的状态，更讽刺的是，此前，7月上任11月离任的Tidmarsh创下的最短CDER主任任期也被Pazdur刷新。（Richard Pazdur接任CDER主任不到一个月就宣布离任）华盛顿枪击案里，一个曾为美国牺牲青春与鲜血的人，被PTSD、语言隔阂和制度缺位一点点推向深渊；在加勒比海，一个政府在没有证据的情况下对外国船只开火，并用“战争迷雾”掩盖真相；在FDA的政府大楼，有经验的领导者陆续出走，取代他们的是一个个资质可疑的外来者。战争结束了，但战争的账从未真正算清。选举结束了，选举的后果却才刚刚开始呈现真正危险的，从来不是一场战斗本身，而是我们看不见、查不到、无法确认的那部分——迷雾遮蔽了原则，遮蔽了责任，也遮蔽了真相。
2025-12-0825 min
Biotech HangoutEpisode 165 - December 5, 2025On this week’s episode, Josh Schimmer, Brian Skorney, Paul Matteis, and Graig Suvannavejh share their outlook for the biotech industry in 2026, including a lively discussion on IPO market and predictions for what to expect next year. The discussion then shifts to Washington, where Tracy Beth Høeg has been appointed acting CDER director -- the fifth person to lead CDER this year -- following Richard Pazdur’s sudden retirement and ongoing staffing volatility at the agency. Next the co-hosts mention the FDA’s moves to speed up drug approvals, the plausible mechanism pathway, and latest with vaccine policies. The FDA’s fin...
2025-12-051h 00
Citeline PodcastsDrug Fix: Understanding the US FDA’s CDER Leadership ShufflePink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18).
More On These Topics From The Pink Sheet
US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Re...
2025-12-0528 min
Pharmaceutical ExecutivePharmaceutical Executive Daily: FDA Names Tracy Beth Høeg as Acting Director of CDERIn today’s Pharmaceutical Executive Daily, the FDA appoints Tracy Beth Høeg as acting CDER director, health systems explore new commercialization partnerships for cell and gene therapies, and Aidoc submits a breakthrough-designated multi-triage AI device for FDA approval.
2025-12-0401 min
CDER écoutons voirCDER écoutons voir - Grand Angle sur les marchés viticoles - Bertrand TREPOLa vendange 2025 en Champagne affiche une belle maturité et un vignoble sain, mais un rendement en baisse, surtout pour le chardonnay, limitant la production à 9000 kg/ha. Malgré une hausse des expéditions vers les États-Unis, la consommation y recule et inquiète la filière. La flavescence dorée progresse, entraînant des arrachages et renforçant la prospection. Bertrand TREPO conclut en souhaitant aux vignerons de bonnes ventes malgré un contexte tendu.
2025-11-2009 min
The Cancer LetterEllen Sigal and Karen Knudsen “gush” about new CDER Director Richard Pazdur and his late wife, MaryLast week, Richard Pazdur was named to the position of director of FDA’s Center for Drug Evaluation and Research. Much has been written about how Pazdur, with nearly a three-decade long career at the agency, represents a stabilizing choice for FDA as it faces inner and outer turmoil.Indeed, on this week’s episode of In the Headlines, we bring you the full audio of a conversation originally published in print in last week’s issue of The Cancer Letter between Ellen Sigal, chair and founder of Friends of Cancer Research, and Karen Knudsen, CEO of the Pa...
2025-11-1929 min
CDER écoutons voirCDER écoutons voir - Grand angle sur l’actualité des entreprises, artisans, commerçants et prestataires de servicesGrand Angle sur l’actualité des entreprises, artisans, commerçants et prestataires de servicesDamien PIECQ, conseiller d’entreprise CDER, décrypte la conjoncture du moment : des entreprises qui se désendettent grâce au remboursement des PGE, mais des investissements en net recul dans un climat économique et politique incertain. Malgré ces tensions, la création d’entreprises reste dynamique, portée notamment par l’hébergement-restauration, le commerce et la réparation auto.Un point clair, utile et concret pour comprendre les enjeux actuels des artisans, commerçants et prestataires de services.
2025-11-1405 min
FDA DirectFDA Direct: Catching Up on Agency ReformsListen as we discuss new CDER leadership, how CDER & CBER will collaborate to bring more consistency to reviews, and the action we took on HRT this week.
2025-11-1329 min
The Cancer LetterTidmarsh is out, Pazdur is in: FDA’s CDER under new leadershipRichard Pazdur, founding director of FDA’s Oncology Center of Excellence and long-time FDA visionary, has accepted the top job at FDA’s Center for Drug Evaluation and Research following George F. Tidmarsh’s dramatic ouster from the position. “This is big. Because, you know, the whole field of oncology over the past 25 years—and [Pazdur has] run the oncology division and decided which drugs would get on the market, which drugs won't get on the market. Everybody is speaking ‘Pazdurese,’” said Paul Goldberg, editor and publisher of The Cancer Letter. “Even if you don't like Pazdur, you are spea...
2025-11-1233 minCiteline PodcastsDrug 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/
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2025-11-0735 min
CDER écoutons voirCDER écoutons voir - Dans les yeux de LudivineDans les yeux de Ludivine, Assistante administrative adhérentsLudivine Bauduin, véritable « bonne fée » du quotidien, accompagne les adhérents de CDER dans leurs tâches administratives : facturation, classement, dématérialisation… Polyvalente et bienveillante, elle apporte organisation, fluidité et sérénité à ceux qu’elle aide. Découvrez un métier clé au service de la relation adhérent et du travail d’équipe.
2025-10-2908 min
Conversations in Drug DevelopmentNavigating the FDA Landscape: More Changes, and What's Next?In this episode, Eric Hardter and guest Kelsey Lenoch discuss recent US FDA developments, including leadership changes at CBER and CDER, staffing impacts on orphan product reviews, and the new Rare Disease Evidence Principles aimed at accelerating approvals for rare and ultra-rare conditions.
They also explore evolving trial endpoints in oncology (including surrogate measures and ctDNA), transparency moves such as the public release of Complete Response Letters and the industry’s reactions, updates on the National Priority Voucher Program, and the FDA Pre-Check initiative to boost domestic drug manufacturing.
Tune in for an in-depth discussion of...
2025-10-2326 min
CDER écoutons voirCDER écoutons voir - Grand Angle sur les marchés des céréales - Cédric WEBERMarchés des céréales : état des lieux automne 2025Les prix du blé poursuivent leur baisse, malgré des récoltes abondantes en Europe, Mer Noire et Amérique du Nord.L’orge de brasserie reste à des niveaux bas, marché fermé pour 2025.Le colza stagne, soutenu par une demande en huile dynamique.Conseil de l’expert CDER : définissez votre stratégie globale, vendez intelligemment et sécurisez vos ventes avec des options pour profiter d’un éventuel rebond.
2025-10-1007 min
BioSpaceM&A Picks Up, Walmsley Moves On, Pfizer’s MFN Deal and Hope for Huntington’sGenmab closed out a busy third quarter for M&A in biopharma, picking up cancer biotech Merus for $8 billion. This deal—the year’s fifth largest—came just a week after Pfizer acquired rising obesity star Metsera for $4.9 billion. Just seven days later, Metsera made the New York–based pharma look like a genius with mid-stage data for one of the deal’s centerpiece therapies, MET-097i, showing 14% placebo-adjusted weight loss over 28 weeks.After months of tarrying and threats, President Donald Trump announced last week that 100% tariffs would take effect Oct. 1—with broad exceptions for companies that have taken s...
2025-10-0122 min
CDER écoutons voirCDER écoutons voir - Dans les yeux d'Alice et MaxenceAujourd’hui, on vous emmène dans les coulisses d’un métier clé : la paie.Découvrez « Dans les yeux d’Alice et Maxence » :Deux gestionnaires paie de l’agence de Soissons nous racontent leur quotidien : bulletins de salaire, conseil social et accompagnement des adhérents. Écoutez vite leur histoire !
2025-09-3007 min
CDER écoutons voirCDER écoutons voir - Regards Croisés sur Horizon CréationLe podcast met en lumière l’offre Horizon Création de CDER, pensée pour accompagner les créateurs et repreneurs d’entreprise. Corentin DAUPHY et Florian BULLE expliquent comment cette offre apporte un soutien complet – diagnostic, prévisionnel, choix juridique, immatriculation – grâce à l’expertise pluridisciplinaire des conseillers, juristes et comptables CDER. Avec le témoignage de Paméla Diné, nouvelle commerçante à Vitry-le-François, découvrez comment un accompagnement structuré et personnalisé favorise la réussite et la pérennité des projets.
2025-09-1611 min
FDA WatchDissecting the Direction of CDER and CBER with Paul Kim Wayne chats with Paul Kim, Principal of Kendall Square Policy Strategies and former head of FDA and federal government strategies practices at a leading law firm for 20 years. Together, they discuss major legal issues and concerns with what the agency is aiming to accomplish; priorities for CDER Director Dr. George Tidmarsh and CBER Director Dr. Vinay Prasad; the direction of CDER and CBER on orphan drugs, rare diseases, and vaccines; reviews under the Commissioner's National Priority Voucher Program; and much more. This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.
2025-09-0241 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
Citeline PodcastsDrug Fix: US FDA’s New Top Drug Regulator, Sarepta’s Options After Elevidys Stand-OffPink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs discuss the issues awaiting George Tidmarsh, the new director of the US Food and Drug Administration’s Center for Drug Evaluation and Research (:24), as well as the next steps for the agency and Sarepta amid the ongoing problems with its gene therapy Elevidys (delandistrogene moxeparvovec) (23:49).
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Will Tidmarsh’s Industry Experience Translate As US FDA’s Chief Drug Regulator?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-news-pharma-ceo-george-tidmarsh-named-director-of-us-fdas-drug-center-2HXJJCPAIVB2RFNGDDU5NZVNQQ/
Business Background Of New CDER Director George Tidmarsh: https://insigh...
2025-07-2536 min
BioCentury This WeekEp. 310 - Sarepta & What's Next for Gene Therapy. Plus: Leading FDA's CDERLast week’s public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA’s platform technology designation. On the latest BioCentury This Week podcast, BioCentury’s analysts unpack the events surrounding Sarepta’s gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic...
2025-07-2231 min
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2025-04-1110 min
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2025-04-1010 min
Radio DiputadosResumen Informativo: semana del 24 al 28 de marzoResumen Informativo de Radio Diputados correspondiente a la semana del 24 al 28 de marzo de 2025, con los testimonios de:▪️Diputado Bruno Sarubi▪️Marcela De Meyer, mujer destacada por la CDER▪️Leticia Angerosa, mujer destacada por la CDER▪️Diputada Carola Laner.▪️Silvina Pérez, coordinadora del Archivo General de la Provincia
2025-03-2805 min
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2025-02-0309 minCiteline PodcastsDrug 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).
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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/
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2024-10-0910 min
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In this episode, Laurie dives into the complexities of FDA compliance programs, specifically focusing on combination product inspections and the 7356.000 Inspections of CDER-led or CDRH-led Combination Products compliance program.
Laurie discusses the definitions, scope, and expectations of combination product manufacturers, addressing the FDA's inspection types, regulatory requirements, and expectations.
Laurie also highlights common misconceptions, especially among contract manufacturers (CMOs) and the importance of proper audit and supplier management practices. Laurie shares insights and practical advice for ensuring...
2024-09-2525 min
Citeline PodcastsDrug Fix: New US FDA Developments In AI RegulationPink Sheet reporter and editors discuss new developments in the FDA’s plans to regulate artificial intelligence and drugs associated with it, including a new AI Council within CDER, as well as some of the unanswered questions about AI in drug development.
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CDER’s New Council Takes Charge Of Oversight, Coordination: https://pink.citeline.com/PS155173/Artificial-Intelligence-CDERs-New-Council-Takes-Charge-Of-Oversight-Coordination AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role: https://pink.citeline.com/PS155156/AI-In-Drug-Development-Regulatory-Clarity-Needed-On-Inspections-Human-Role
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‘Antiquated’ Regulations Slowing Adoption of Innovative Clinical Trial Approaches: https://pink.citeline.com/PS154730/Antiquated-Regulations-Slowing-Adoption-of-Innovative-Clinical-Trial-Approaches
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NIH Drug Patent Licensees Would Develop ‘Acc...
2024-05-2423 min
Progress, Potential, and Possibilities Podcast / ShowDr. Kevin Bugin, Ph.D. - Deputy Director of Operations, Office of New Drugs, CDER, U.S. FDA - Clinical Trial Innovation To Improve The Efficiency And Effectiveness Of Drug DevelopmentSend us a textDr. Kevin Bugin, Ph.D. is Deputy Director of Operations in the Office of New Drugs ( OND - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-new-drugs ) in FDA’s Center for Drug Evaluation and Research ( CDER - https://www.fda.gov/about-fda/fda-organization/center-drug-evaluation-and-research-cder ), where among his many responsibilities he serves as lead for the Center for Clinical Trial Innovation ( C3TI - https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-center-clinical-trial-innovation-c3ti ), a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct. Prior to his cur...
2024-05-2255 min
Pharmacy Podcast NetworkA Step Forward in the Treatment of Opioid and Alcohol Dependence with Dr. Iilun Murphy and Dr. Marta Sokolowska | Q&A with FDAThe rates of alcohol use disorder increased significantly since the onset of COVID-19, making this a major public health issue, though it’s not discussed as frequently as opioid overdoses. Over 140,000 Americans die from the effects of alcohol in an average year (more than from drug overdoses). Ten percent of Americans over the age of 12 have Alcohol Use Disorder. And according to the 2023 Alcohol Abuse Statistics, 60% of Americans increased their alcohol consumption during COVID-19 lockdowns.
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PharmaTalkRadioFDA Update on Digital Health Technologies in Clinical Trials Draft GuidanceMobile in Clinical Trials is joined by the FDA who will provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical trial participants. Following the discussion, the FDA representatives hold open Q&A. Topics include: Guidance updatesThe requirements to test all of these digital health technologiesEfforts the agency is putting in place to harmonize the requirements across the boardGuidance to the industry in terms of how we create the harmonization. What do we need to disclose? And in what timeframe?FDA update on approval...
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Let's Combinate - Drugs + Devices049 - "What Does the Data Say?" with Shannon HosteOn this episode of the podcast, I was joined by Shannon Hoste, President of Agilis Consulting. Shannon and I discuss:
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- Risk Management and User Risk
- Summative HF Evaluation and Sampling
Shannon is the President of Agilis Consulting Group, an assistant professor in the Quality Science Education program at Pathway for Patient Health and is active on several standards and conference committees for medical devices and combination...
2022-09-0746 min
Drug SolutionsFDA Chats about Drug Quality, Innovation and What Drives Them ForwardQuality will forever be a topic of discussion for the pharmaceutical industry, and who better to share their insight than FDA? Three representatives from FDA—Michael Kopcha, Sau Lee, and Cindy Buhse—join Chris Spivey, editorial director, for a discussion about 1) emerging technology programs; 2) the framework for regulatory advanced manufacturing evaluation; 3) quality management maturity ratings; 4) quality of pharmaceuticals and its relatability to other variables, such as economics; 5) continuous vs. batch manufacturing; 6) pandemic pressures and improved communication; 7) keeping up with biotech and emerging therapies; and 8) what manufacturers need to know.
SPEAKERS:
Michael Kopcha, PhD, R.Ph., director of the FDA’s Office...
2022-05-1744 min
Eco AlarmEp. 12: Can Nature Have Its Own Rights?This week we talked to Mari Margil, executive director at the Center for Democratic and Environmental Rights (CDER)! CDER works with governments, tribal nations, indigenous communities, civil society, and grassroots activists to protect the human right to a healthy environment and establish the rights of the environment itself – the rights of nature. This means securing the highest level of legal protection for humans and nature through the recognition of legal rights. Tune in to hear more about Mari's recent work and get an inside scoop on how CDER accomplishes these goals!
Action Items:
Follow @centerforenvironmentalrights
Visit the...
2022-03-2553 min
Political Pharmacist PodcastEpisode 120 - Deserving of Better Medicare with 3 Axis AdvisorsHave you ever wondered why Medicare Part D has so many clawbacks?
Say no more! The amazing folks at 3 Axis Advisors put together an amazing study that highlights this, how to fix it and do it with some amazingly easy to understand graphics! Dr. Ben Link and Dr. Matthew Wine are amazing guests and researchers on this episode who will give you the quick and dirty on their latest major report AND some actionable steps to fix it. What's the point of bringing problems to light if you don't have solutions?
Link to the study discussed in most of the...
2022-03-1848 min
Real Talk: Eosinophilic DiseasesDrug 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
Pharmacist's VoiceInterview with Renu Lal, PharmD - Lieutenant Commander, U.S. Public Health Service Commissioned CorpsRenu Lal, PharmD, is a Team Lead in the Division of Drug Information (DDI) within the Food and Drug Administration/Center for Drug Evaluation and Research/Office of Communications. Along with directly communicating with the public, the Division is responsible for many initiatives and outreach programs such as the CDER Small Business and Industry Assistance (SBIA) Program; FDA Drug Info Rounds video; Drug Safety podcasts; Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.), Webinars for healthcare professionals and students, and more. Renu is an officer in the Commissioned Corps of the U.S. Public Health Service...
2021-11-1937 min
Trending HealthCompliance and the Future of Customer EngagementWith the explosion of digital channels and accompanying shifts in customer preferences, life sciences are reshaping their customer engagement models across commercial, medical, and market access organizations. In this episode, Jen and Mindy are joined by special guest Hunter Goga to how the customer engagement model has evolved and what leaders should be considering from a compliance perspective as they look to innovate in this space. Traditionally siloed interactions are evolving (00:47) in both who and how life science companies are engaging with customers (02:09). This evolution to a true omnichannel approach is not without its pain points (05:36) both operationally and...
2021-10-2817 min
Boyes MusikkompaniAnmeldelserEtter å ha gitt ut noen album hver har vi blitt konfrontert med et litt tvilsomt fenomen som eksisterer på noen platformer hvis virke er å publisere anmeldelser av CDer. Vi snakker om våre erfaringer og hva man bør være obs på når man leser anmeldelser. Her er et eksempel vi gir på en god platform for å lese anmeldelser: https://acloserlisten.com
2021-09-3038 minBoyes MusikkompaniAnmeldelserEtter å ha gitt ut noen album hver har vi blitt konfrontert med et litt tvilsomt fenomen som eksisterer på noen platformer hvis virke er å publisere anmeldelser av CDer. Vi snakker om våre erfaringer og hva man bør være obs på når man leser anmeldelser.
Her er et eksempel vi gir på en god platform for å lese anmeldelser: https://acloserlisten.com
2021-09-2938 min
Parlons agriculture ou viticulture · RCF Cœur de Champagne[AGRI] Les conditions climatiques de la récolte 2021 et la betterave sucrièreLes conditions climatiques de la récolte 2021 et la culture « Betteraves à sucre et ses déboires… » Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.
2021-09-0129 min
Health Equity ForumPrEP and PEP for HIV Prevention in Older AdultsIn this episode, we'll be talking about the use of medication regimens known as PrEP and PEP as part of HIV prevention strategies for older adults with Dr. Debra Birnkrant, MD, Director, Division of Antivirals, Center for Drugs Evaluation and Research (CDER).
2021-08-2716 min
Parlons agriculture ou viticulture · RCF Cœur de ChampagneTour d'actualité champenoiseParlons viticulture et principalement la prochaine récolte et les actions de sortie de crise avec Bertrand Trépo, responsable du marché viticole à CDER.
2021-06-3029 minParlons agriculture ou viticulture · RCF Cœur de ChampagneLes marchés agricolesLes marchés agricoles avec Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.
2021-06-2328 min
ToxChats©Expedited FDA ProgramsThe FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation. To expedite the evaluation of new drugs and review of marketing applications for drugs addressing unmet medical needs for patients with serious or life-threatening conditions, the FDA has established four expedited programs: Fast Track Designation, Breakthrough Therapy Designation, Priority Review, and Accelerated Approval. This episode examines FDA Expedited Programs with CDER’s Senior Regulatory Expedited Programs Ma...
2021-06-1723 min
The Peds NP: Pearls of Pediatric Evidence-Based PracticeHeat and Sun Issues in Summer (S3 Ep. 24)As the hottest part of summer approaches and kids spend more time playing outside, pediatric providers need to be ready to recognize heat-related illness and offer savvy perspectives on how to protect kids from the sun's harmful rays.
References:
American Academy of Pediatrics. (2011). Ultraviolet radiation: A hazard to children and adolescents. Pediatrics, 127(3), 588-597. doi:10.1542/peds.2010-3501
Center for Biological Diversity. (2021, March 9). Hawai’I senate bill bans harmful sunscreen chemicals. https://biologicaldiversity.org/w/news/press-releases/hawaii-senate-bill-bans-harmful-sunscreen-chemicals-2021-03-09/
Mangus, C.W., & Canares, T.L. (2019). Heat-related illness in children in an era of e...
2021-06-0213 minParlons agriculture ou viticulture · RCF Cœur de ChampagneLes défis de la Champagne après la crise Covid-19Parlons viticulture et principalement des défis de la Champagne après la crise Covid-19 avec Bertrand Trépo, responsable du marché viticole à CDER.
2021-06-0228 minParlons agriculture ou viticulture · RCF Cœur de ChampagneLa révolution numérique en agricultureDans notre émission de ce jour, nous présenterons les outils et bénéfices du numérique en agriculture avec Jean-Marie Lett, responsable du service-conseil chez CDER, au micro d'Hubert Cartel.
2021-05-2628 min
Dialogpodden TunsbergFrøydis GrorudFrøydis Grorud har blitt folkeeie gjennom sine 20 år i Beat for Beat i NRK. Hun turnerer mye med ulike konstellasjoner og har gitt ut en lang rekke CDer. Frøydis er en utrolig positiv og hyggelig person som gir av seg selv gjennom musikken - om det er i Beat for Beat, på et eldrehjem eller på Slottet. I denne samtalen snakker vi om hennes oppvekst i Skien og hvordan musikken veldig tidlig fylte både tid og oppmerksomhet. Musikken er et språk som kan formidle på et nivå der ord kommer til kort. Det er fantasti...
2021-05-131h 00Parlons agriculture ou viticulture · RCF Cœur de ChampagneLes vignes de champagne et le climatParlons viticulture et principalement du gel et de la réserve individuelle en champagne avec Bertrand Trépo, responsable du marché viticole à CDER.
2021-05-0527 min
Take Once a Week (QW)Take Once a Week April 21: J&J Recall and Saline Shots
https://www.biopharmadive.com/news/johnson-johnson-vaccine-pause-supply-acip-hesitancy/598335/
https://www.biopharmadive.com/news/fda-cder-cavazzoni-woodcock-successor/598235/
2021-04-2103 min
BioCentury This WeekEp. 53 - Competence & Continuity at CDER; plus BIO 3.0, AACR and 2Q PreviewReach us by sending a text
2021-04-1323 min
The Huddle: Conversations with the Diabetes Care TeamSupporting Clients Who Take Supplements for Cardiometabolic HealthNational Center for Complementary and Integrative Medicine: http://nccih.nih.gov.Natural Medicines: https://naturalmedicines.therapeuticresearch.com/.FDA tainted product list: https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=1d&sd=tainted_supplements_cder&page=1.Tips for Dietary Supplement Users: https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110567.htm.Tips for Older Dietary Supplement Users: https://www.fda.gov/Food/DietarySupplements/UsingDietarySupplements/ucm110493.htm.HerbList App (free from NIH): https://www.nccih.nih.gov/health/herblist-app.Merck Manual Online Chapter on Dietary Supplements (for consumers and health care professionals): https://www.merckmanuals.com/professional/special-subjects/dietary-supplements/overview-of-dietary-supplements...
2021-02-1720 min
Medtech MattersCDRH 2021 PrioritiesIn this Medtech Matters podcast episode of Mike on Medtech with Mike Drues, president of Vascular Sciences, we discuss a number of the priorities Dr. Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH), has mentioned in recent presentations. The agency had also laid out several priorities in a document a few years ago to be acted upon from 2018 through 2020, which has now been extended to 2021. Specifically, we address a number of questions, including:What are the important priorities for CDRH in 2021?Tracking of submissions and electronic templatesDecentralized clinical trials with CDER and...
2021-01-0846 min
Katten i SækkenKatten i Sækken #80 - November 2020Dreamers Circus udnævnt til Specialensemble af Statens Kunstfond, ny Cder m. bl.a. Gunni Torp og Chr. Søgaard Trio, julebudskab fra Mads Hansens kapel, trofast folkemusikspillested lukker, og meget, meget mere.
2020-12-131h 15
FDA InsightHand Hygiene During COVID-19Dr. Shah welcomes Elizabeth Jungman, director of CDER’s Office of Regulatory Policy, to talk about hand sanitizers and the COVID-19 pandemic.
2020-11-1011 min
Data & Science with Glen Wright ColopyInnovative Trial Design & Master Protocols: Lisa Lavange | Pod of AsclepiusLisa LaVange (Gillings School of Global Public Health at the University of North Carolina at Chapel Hill) was the 2018 American Statistical Association (ASA) president and the director of the Office of Biostatistics in the Center for Drug Evaluation and Research (CDER) at the FDA.
She give a high-level overview of issues surrounding Innovative Trial Design and Master Protocols. A great listen for anyone wanting to be introduced to the subject or (for those already familiar) interested in its growing breadth of applications.
#datascience #statistics #biopharm #pharma #FDA
2020-09-0944 min
TelefonJokes med Palle BoKaren Busck og genanvendte CDerGod fornøjelse med dagens TelefonJoke med Palle Bo. Abonnér på podcasten:Apple Podcast Spotify TelefonJokes Podcast er sponsoreret af Hotels25.dk, som kan hjælpe dig med at finde den skarpeste pris på hotelværelse og hostels rundt omkring i hele verden. Det gør den ved at søge en række af de store hotelsøgesider i én enkelt søgning. Grinte du? Så deler du den vel med dine venner...?
2020-09-0404 min
Keck Graduate Institute: Insights and innovations in Healthcare, Biotech, and Life Sciences Research#119 - Dr. Steven GalsonAs part of the Pandemic Solutions: Virtual Speaker Series, KGI’s Rajesh Parti interviewed Dr. Steven Galson, Senior Vice President of Global Regulatory Affairs and Safety at Amgen. Dr. Galson has more than 20 years of experience in government service, including two years as acting Surgeon General of the United States. Previously, he served as director of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), where he provided leadership for the center’s broad national and international programs in pharmaceutical regulation.
2020-07-1656 min
The Lev Natan Podcast22. Rights of Nature (Part Two): Giving Ecosystems a Voice in Court - Mari Margil“Mari Margil serves as the Executive Director of Center for Democratic and Environmental Rights (www.centerforenvironmentalrights.org) and program manager for CDER’s International Center for the Rights of Nature. In 2008, she served as a consultant to Ecuador’s national Constituent Assembly, helping to draft the world’s first Rights of Nature constitutional provisions. Margil is widely viewed as one of the leading global voices for the recognition of legally enforceable rights of ecosystems and nature.” In this interview, she speaks to how the Rights of Nature movement is bringing together unlikely partners in business, government and civil society to collaborat...
2020-07-0348 min
Deceleration Podcast14: Rights of Nature Movement Reaches San AntonioDeceleration talks with attorneys and organizers affiliated with the Center for Democratic and Environmental Rights (CDER) about the Rights of Nature movement globally, as well as what it might look like locally in San Antonio.Support the showDeceleration.news: 'For the Earth. And all Her families.'
2020-06-0632 min
CDER écoutons voirParoles d’experts CDER - La Visite Médicale en Entreprise - Laurianne CourcelleLaurianne Courcelle, Gestionnaire Paie nous présente "La visite médicale en entreprise".
*enregistrement réalisé en 2019.
2020-05-2901 min
CDER écoutons voirParoles d’experts CDER - Généralisation Complémentaire Santé - Nicolas CHARBAUTNicolas CHARBAUT, Gestionnaire Paie nous présente "Généralisation Complémentaire Santé".
*enregistrement réalisé en 2019.
2020-05-2101 min
CDER écoutons voirParoles d’experts CDER - L’impact du covid 19 sur le secteur du BTP - Laëtitia SACRELaëtitia SACRE, Conseillère d'entreprise nous présente "Les conséquences du Covid-19 sur le BTP".
*enregistrement réalisé le 7 mai 2020.
2020-05-1503 min
CDER écoutons voirParoles d’experts CDER - L’impact du covid 19 sur la création d’entreprises - Louis TRANLouis TRAN, Conseiller d'entreprises, nous présente "L’impact du covid 19 sur la création d’entreprises".
*podcast enregistré : 16 Avril 2020
2020-04-2702 min
CDER écoutons voirParoles d’experts CDER - Les salons de coiffure et les instituts de beauté face au COVID-19Elizabeth DE OLIVEIRA, conseillère d'entreprise, nous présente "Les salons de coiffure et les instituts de beauté face au COVID-19".
*enregistrement réalisé le 21 avril 2020
2020-04-2702 min
CDER écoutons voirParoles d’experts CDER - Les conséquences du COVID-19 sur les cafés, hôtels et restaurantsBenjamin BEURVILLE, Responsable équipe conseil, nous présente "Les conséquences du COVID-19 sur les cafés, hôtels et restaurants".
*podcast enregistré : 17 Avril 2020
2020-04-2702 min
The Science Revolution with Thom HartmannCould Another Zoonotic Pandemic be Coming to America?On this week's Science Revolution: Zach Corrigan with Food & Water Watch - Could another zoonotic pandemic be coming? Thomas Linzey Esq. with the Center for Democratic and Environmental Rights (CDER) is here on the rights of nature, and how it may have helped protect Pennsylvania from industry harm. Friends of the Earth's Lukas Ross is dropping by on the big oil bailout & how fracking may be next. Plus - Arthur West with Washington League for Increased Transparency and Ethics (WASHLITE) is suing Fox-So-Called-News for endangering Americans in calling the coronavirus a hoax! Can he win? Check...
2020-04-1300 min
The Parexel PodcastEpisode 8: Performing clinical trials in a shifting development landscapeThe COVID-19 pandemic is having lasting and far-reaching impact on the drug development industry. Fundamental aspects of drug development are undergoing changes that were unimaginable just weeks ago. However, the pursuit of new medicines cannot stop. Learn from Parexel regulatory experts Amy McKee, an oncologist and former FDA CDER regulator; Bridget Heelan, a former senior clinical assessor in the biological unit at the MHRA; and Jenny Gidley, global head of Parexel’s Clinical Operations Leaders about the implications of this pandemic for the important work of drug developers, researchers, and regulators. How are we to cope with the new re...
2020-04-0823 min
CDER écoutons voirParoles d’experts CDER - Les impacts du Covid-19 sur l’agriculture française - Jean-Marie LETTJean-Marie LETT, Directeur Métier Conseil, nous présente “Les impacts du COVID-19 sur l’agriculture française “.
*enregistrement réalisé le 31 mars 2020
2020-04-0305 min
CDER écoutons voirParoles d'experts CDER - Conjoncture viticole : 1ère conséquences du Covid-19 - Bertrand TREPOBertrand TREPO, Responsable Marché Viticole, fait un point sur les premières conséquences du Covid19 pour les viticulteurs champenois.
*enregistrement réalisé le 27 mars 2020
2020-04-0303 min
Talk to Your PharmacistMade in ChinaRx with Author, Rosemary GibsonIn this episode, our guest is Rosemary Gibson, author of ChinaRx, senior advisor at the Hastings Center, and recipient of a 2019 Pinnacle Award for career achievement from the American Pharmacists Association Foundation.
We discuss:
- Why she wrote the book? Most Americans taking prescriptions or OTC meds have no idea where there medication came from or why that might be a concern.
- How did she research this topic? even pharmacy leaders are in here - Lucinda Maine of AACP
- Two major concerns in book: 1) risky for US to become dependent on any one country 2) lapses in safety standards...
2020-02-2326 min
Stats + StoriesThe Philosophy of Biostatistics | Stats + Stories Episode 124Dr. Harrell is the founding chair of the Vanderbilt Biostatistics department. Since 2003 he has been Professor of Biostatistics, Vanderbilt University School of Medicine, and was the department chairman from 2003-2017. He is Expert Statistical Advisor for the Office of Biostatistics for FDA CDER. He is Associate Editor of Statistics in Medicine, a member of the Scientific Advisory Board for Science Translational Medicine, and a member of the Faculty of 1000 Medicine. He is a Fellow of the American Statistical Association and winner of the Association's WJ Dixon Award for Excellence in Statistical Consulting for 2014. His specialties are development of accurate prognostic...
2020-01-3007 min
Stats + StoriesThe Stats Behind Your Medical Care | Stats + Stories Episode 121Dr. Harrell received his PhD in Biostatistics from UNC in 1979. Since 2003 he has been Professor of Biostatistics, Vanderbilt University School of Medicine, and was the department chairman from 2003-2017. He is Expert Statistical Advisor for the Office of Biostatistics for FDA CDER. He is Associate Editor of Statistics in Medicine, a member of the Scientific Advisory Board for Science Translational Medicine, and a member of the Faculty of 1000 Medicine. He is a Fellow of the American Statistical Association and winner of the Association's WJ Dixon Award for Excellence in Statistical Consulting for 2014. His specialties are development of accurate prognostic and...
2020-01-0930 min
Værings Værksted - en podcast om sangskrivningVandskræk - Trinelise Væring om en sang fra albummet “Du går ind ad en dør”“Vandskræk”er en klaver båren ballade med bløde blæsere. Trinelise Væring tager os med ind under huden på teksten og fortæller hvordan, hun i dag kan høre, at musikken trækker en lige linje tilbage til den amerikanske sangskriver Janis Ian, som Trinelise lyttede til i sine teenageår. Til aller sidst i programmet ligger en liveudgave (uropførelsen) af sangen.
I VÆRINGS VÆRKSTED inviterer Trinelise Væring indenfor i sit sangskriverværksted. Podcast for podcast, sang for sang fortæller hun om arbejdet med både tekst og musik, fra første skitse til den...
2020-01-0732 min
Værings Værksted - en podcast om sangskrivningThe Leopard Doesn’t Change His Spots - Trinelise Væring om en sang fra “Du går ind ad en dør”“The Leopard Doesn’t Change His Spots” har været vidt omkring. Oprindelig blev den den skrevet på engelsk under et ophold i Austin Texas. Trinelise Væring fortæller om transformationen fra engelsksproget americana til den endelige danske version af sangen, som den ligger på hendes seneste album.
I VÆRINGS VÆRKSTED inviterer Trinelise Væring indenfor i sit sangskriverværksted. Podcast for podcast, sang for sang fortæller hun om arbejdet med både tekst og musik, fra første skitse til den færdige indspilning af sangene på hendes anmelderroste album ”Du går ind ad en dør”.
VÆRINGS VÆRKS...
2020-01-0727 min
BrotoGPYou & Andrea Iannone might accidentally be taking PEDs | Ep. 129Do you take supplements? Are you absolutely certain there are no illicit or banned substances in them? How do you know?Andrea Iannone has almost failed a drug test, with his A-sample containing an anabolic steroid. BrotoGP has no idea what's going to happen to his career just yet. But first, Kev wants to set a few things straight. #1 - Its very possible to unknowingly consume a tainted supplement. #2 - PEDs would benefit motorcycle racing in more ways than you might think. This goes deep.After that, we hit up MotoAmerica's loss of the Yoshimura team...
2019-12-231h 13
FDA ** CDER Small Business and Industry Assistance (SBIA) ChroniclesImproving Regulatory Communication via the CDER NextGen PortalThe CDER NextGen Portal (or the “Portal” for short) has made it easier than ever for regulated industry to communicate with the FDA.
2019-12-1906 minKatten i SækkenKatten i Sækken #66 (RESUMÉ 50 min) - September 2019Katten i Sækken #66, september 2019 - Ny Cder, interview m. folk fra det spritny band 'Viik', interview m. Julien fra Mads Hansens kapel om OO-Award, interview m. Rod Sinclair om Burns CD.m.m.
2019-10-1749 minKatten i SækkenKatten i Sækken #66 - September 2019Ny Cder, Live-optagelser fra Folk Spot Denmark, interview m. folk fra det spritny band 'Viik', interview m. Julien fra Mads Hansens kapel om OO-Award, interview m. Rod Sinclair om Burns CD.m.m.
2019-10-101h 20
Værings Værksted - en podcast om sangskrivningPå en skala fra 1 til 10 - Trinelise Væring om en sang fra albummet “Du går ind ad en dør”“På en skala fra 1 til 10, hvor meget har du så at ha’ det i?” Sådan lidt vel sarkastisk starter denne finurlige ballade. Trinelise Væring fortæller om tekst og musik.Hun fortæller bl.a. hvordan både Bach og Procol Harum har inspireret hende til instrumentation og arrangement.
I VÆRINGS VÆRKSTED inviterer Trinelise Væring indenfor i sit sangskriverværksted. Podcast for podcast, sang for sang fortæller hun om arbejdet med både tekst og musik, fra første skitse til den færdige indspilning af sangene på hendes anmelderroste album ”Du går ind ad en dør”.
VÆRINGS V...
2019-10-0621 min
Værings Værksted - en podcast om sangskrivningTag Mig - Trinelise Væring om en sang fra albummet “Du går ind ad en dør”Trinelise Væring fortæller om sangen “Tag Mig” fra albummet “Du går ind ad en dør”, en sang hun oprindelig troede ikke skulle med på albummet, men som er endt med at være en af de sange både hun og publikum er aller gladest for.
I VÆRINGS VÆRKSTED inviterer Trinelise Væring indenfor i sit sangskriverværksted. Podcast for podcast, sang for sang fortæller hun om arbejdet med både tekst og musik, fra første skitse til den færdige indspilning af sangene på hendes anmelderroste album ”Du går ind ad en dør”.
VÆRINGS VÆRKSTE...
2019-09-0620 min
Værings Værksted - en podcast om sangskrivningKeine Hexerei - Trinelise Væring om en sang fra albummet "Du går ind ad en dør"Man kunne måske godt tro, at Trinelise Væring har skrevet en sang på tysk. Men Keine Hexerei er faktisk en sang på dansk, og det er oven i købet en kærlighedssang, der tager fat dér, hvor “og-så-levede-de-lykkeligt-til-deres-dages-ende” slet ikke rækker.
I VÆRINGS VÆRKSTED inviterer Trinelise Væring indenfor i sit sangskriverværksted. Podcast for podcast, sang for sang fortæller hun om arbejdet med både tekst og musik, fra første skitse til den færdige indspilning af sangene på hendes anmelderroste album ”Du går ind ad en dør”.
VÆRINGS VÆRKSTED er bå...
2019-08-2017 min
SkamfrelstEp. #62 - "TOOL, Trumps ord og jeg vil også føle rasisme"Her er det godt mulig jeg er ute og kjører, men føler å gå igjennom livet på Level Easy kanskje gjør meg til et mindre menneske. Er veldig glad for at jeg ikke opplever rasisme samtidig som jeg tror det gjør meg til et kjedeligere menneske. TOOL er også ute med ny sang og det får mimringen på glid. Fjortiser på platebutikken Platon på Bystasjonen og hørte på CDer. Good Times. Og så litt ranting om Trump og idioter.https://www.patreon.com/skamfrelstChristoffer på InstagramChristoffer på F...
2019-08-1938 min
Eric & Helen ShowHealth: Nearly 800 Dietary Supplements Contain Active Ingredients Not Approved by FDA/Story: Red Flower Goes West.Nearly 800 Dietary Supplements Contain Active Ingredients Not Approved by FDA
Between 2007 and 2016, 776 over-the-counter dietary supplements contained at least one pharmaceutical ingredient associated with an adverse warning from the U.S. Food and Drug Administration (FDA), according to a new study.
Researchers for JAMA used data from the FDA’s Center for Drug Evaluation and Research, Tainted Products Marketed as Dietary Supplements_CDER database from 2007 through 2016 to identify adulterated (containing unapproved ingredients) dietary supplements. They found the FDA had identified 776 adulterated dietary supplements (746 distinct products), implicating 146 different companies. In most cases (757 of 776 [97.6%]), these ingredients were not stated on the product label. Most...
2018-10-2609 min
FDA Drug Information UpdatesThe FAERS Public Dashboard and its Value to the Pharmaceutical Industry
The FDA has made strides in improving transparency and data access, and has implemented tools to allow the pharmaceutical industry and the public to transform raw data into usable information. One of these tools is called the FDA Adverse Event Reporting System (FAERS) Public Dashboard. In this episode, the architects of the FAERS Public Dashboard – Deputy Director of the Regulatory Science Staff Suranjan De, and Acting Team Lead in Regulatory Science Information Sanjay Sahoo—both of CDER’s Office of Surveillance and Epidemiology, highlight their work with this new online tool.
2018-07-3100 min
Lekendelett Podcast - med Kjetil FyllingenLekendelett intervju med Chris Duwe - 5 gode tips om hvordan du kan formidle en levende tro hjemme!Har du hørt om «Øystein og Chris»?
Chris Duwe er en veldig bra mann, som har mange spennende prosjekt på gang.
I dette intervjuet med Chris Duwe får du høre mer om:
Hva er det Chris egentlig jobber med, og drømmer om?
Hvorfor begynte Chris med buktaling?
Hvor mange CDer har Chris delt ut i Norge og i Tyskland?
Hva skjer i til Chris for tiden?
Hva er Chris sine 5 beste tips til hvordan foreldre kan formidle en levende tro i hjemmet?
Sjekk ut:
Chris på YouTube
Chris på Facebook
Ellestakk.no (Her kan du bestille CDer med Øystein og Chri...
2018-06-0642 min
Human Factors Cast#HFESHealth 2018 Bonus EP2Today is March 28th, 2018 and it's an all new Human Factors Cast hosted by Nick Roome with Blake Arnsdorff dand Elyse Hallett.
This is the second #HFESHealth 2018 bonus episode!
We talk about all the exciting news coming out of HFES Healthcare Symposium in Boston!
Electronic Health Records: Solving the little data problem
Evaluation of Tactile Technology for continuous informing displays in Anesthesia.
Augmented Reality: The Future of Medic Training
FDA CDRH / CDER panel: Medical Device HF
Follow us on LinkedIn:
https://www.linkedin.com/company/humanfactorscast
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http://www.twitter.com/HFactorsPodcast
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2018-03-2950 minFDA Drug Information UpdatesThe FDA's Adverse Event Reporting System (FAERS) Public Dashboard
Many listeners may be familiar with the FDA's Adverse Event Reporting System or FAERS. Data in FAERS supports the FDA's post-marketing safety surveillance program for drug products and therapeutic biologic products. Recently, CDER's Office of Surveillance and Epidemiology created and released a tool that makes FAERS data easier to query and retrieve. This new interactive dashboard is designed to expand access of FAERS data to the general public. Dr. Janet Woodcock, Director of the FDA Center for Drug Evaluation and Research, discusses the advantages of the tool as well as its limitations.
2017-10-2900 min