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

Published Mar 16, 2018Updated Jun 21, 2025

The Congressional Research Service is a nonpartisan policy and legal analysis arm of the Library of Congress. CRS reports are written for members of Congress and their staff, not the public — but they’re made available openly through Congress.gov.

FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Dr… — Informed