Risk Evaluation and Mitigation Strategies (REMS) Compliance Program

  Рет қаралды 13,672

U.S. Food and Drug Administration

U.S. Food and Drug Administration

Күн бұрын

Haley Seymour from CDER’s Division of Enforcement and Postmarketing Safety (DEPS) providess an overview of the REMS Compliance Program. The REMS Compliance team develops risk-based enforcement and communication strategies that ensure that drugs approved have reliable evidence of safety and effectiveness by ensuring that they meet post-market safety requirements.
Learn more at: 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 - www.fda.gov/cdersbia
SBIA Listserv - public.govdelivery.com/accoun...
SBIA 2021 Playlist - • 2021 CDER Small Busine...
SBIA LinkedIn: / cder-small-business-an...
SBIA Training Resources - www.fda.gov/cdersbialearn
Twitter - / fda_drug_info
Email - CDERSBIA@fda.hhs.gov  
Phone - (301) 796-6707 I (866) 405-5367

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