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FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development
This report provides a brief history of FDA drug regulation, describes FDA's early risk management programs, and focuses on the agency's current risk management authorities, specifically risk evaluation and mitigation strategies (REMS). The report also discusses issues that have arisen as a result of REMS, particularly the impact on generic drug competition. It does not discuss antitrust issues raised by restricted distribution systems.
Date:
April 11, 2017
Creator:
Dabrowska, Agata
System:
The UNT Digital Library