Dabrowska, Agata,

FDA Risk Evaluation and Mitigation Strategies (REMS) : description and effect on generic drug development / Food and Drug Administration Risk Evaluation and Mitigation Strategies (REMS) Agata Dabrowska. - [Library of Congress public edition]. - 1 online resource. - Report / Congressional Research Service ; R44810 . - CRS report ; R44810. .

The CRS report home page provides access to all versions published since 2018 in accordance with P.L. 115-141. CRDP Program record.

Report includes bibliographical references.

2018253160


United States. Food and Drug Administration.


Generic drugs.
Pharmaceutical industry--United States.
Pharmaceutical industry--Materials management--United States.

0807-A-07 (online)

LC 14.23:R 44810/