A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs-Reference-Cited by-同舟云学术

A Multi-modal Approach to Evaluate the Impact of Risk Evaluation and Mitigation Strategy (REMS) Programs

Published:2021-04-27 Issue: Volume: Page:
ISSN:0114-5916
Container-title:Drug Safety
language:en
Short-container-title:Drug Saf

Author:

Sarpatwari Ameet^ORCID,Mitra-Majumdar Mayookha,Bykov Katsiaryna,Avorn Jerry,Woloshin Steven,Toyserkani Gita A.,LaCivita Cynthia,Manzo Claudia,Zhou Esther H.,Pinnow Ellen,Dal Pan Gerald J.,Gagne Joshua J.,Huybrechts Krista F.,Feldman William B.,Chin Kristyn,Kesselheim Aaron S.

Funder

U.S. Food and Drug Administration

Arnold Ventures

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology,Toxicology

Link

https://link.springer.com/content/pdf/10.1007/s40264-021-01070-2.pdf

Reference21 articles.

1. Avorn J, Kesselheim A, Sarpatwari A. The FDA Amendments Act of 2007: assessing its effects a decade later. N Engl J Med. 2018;379(12):1097–9.

2. Pub L No 110–85, 121 Stat 823 (September 27, 2007).

3. 21 USC § 355-1.

4. United States Food and Drug Administration. Approved risk evaluation and mitigation strategies (REMS). https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm. Accessed 17 Mar 2021.

5. United States Department of Health and Human Services Office of Inspector General. FDA lacks comprehensive data to determine whether risk evaluation and mitigation strategies improve drugs safety. February 2012. https://oig.hhs.gov/oei/reports/OEI-04-11-00510.asp. Accessed 17 Mar 2021.

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