FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development

Dabrowska, Agata

Library of Congress. Congressional Research Service.

关键词: Drug industry;    Drug approvals;    Medicine;    Product safety;    generics;   

RP-ID  :  R44810
RP-ID  :  R44810_2017Apr11

美国|英语

来源: UNT Digital Library

【 摘 要 】

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.