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 law and legislation;    Government regulation;    Generic drugs;    Drug industry;   

RP-ID  :  R44810
RP-ID  :  R44810_2018Mar16

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. While this report generally focuses on REMS in the context of generic drug development, the issues discussed are also relevant to biological and biosimilar product development.