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ClinicalTrials.gov: Part 3 - CDER’s Compliance and Enforcement Activities 10 месяцев назад


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ClinicalTrials.gov: Part 3 - CDER’s Compliance and Enforcement Activities

Part three of a three-part webinar series, FDA provides an understanding of CDER’s role and responsibilities with respect to ClinicalTrials.gov oversight; including examples of compliance and enforcement activities CDER has taken to encourage compliance. Speakers: Rachelle Swann, Pharm.D. Lead Pharmacologist Division of Enforcement and Postmarketing Safety (DEPS) Office of Scientific Investigations (OSI) Office of Compliance (OC) Center for Drug Evaluation and Research (CDER) | FDA Learn more at: https://www.fda.gov/drugs/news-events... ----------------------- FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research. Upcoming Training - https://www.fda.gov/cdersbia SBIA Listserv - https://public.govdelivery.com/accoun... SBIA 2022 Playlist -    • 2022 CDER Small Business and Industry...   SBIA LinkedIn -   / cder-small-business-and-industry-assistance   SBIA Training Resources - https://www.fda.gov/cdersbialearn Twitter -   / fda_drug_info   Email - [email protected] Phone - (301) 796-6707 I (866) 405-5367

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