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: [ Ссылка ]
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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.
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