Analysis of risk evaluation and mitigation strategies for teratogenic drugs: Variation in primary and secondary prevention measures

Author:

Brown Beatrice L.,Kesselheim Aaron S.ORCID,Sarpatwari AmeetORCID

Funder

Arnold Ventures

Publisher

Public Library of Science (PLoS)

Subject

General Medicine

Reference25 articles.

1. The FDA Amendments Act of 2007—assessing its effects a decade later;J Avorn;N Engl J Med,2018

2. Mitigating health risks of prescription drugs: lessons From FDA oversight of opioid products;A Sarpatwari;JAMA,2019

3. A multi-modal approach to evaluate the impact of risk evaluation and mitigation strategy (REMS) programs;A Sarpatwari;Drug Saf,2021

4. iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). U.S. Food and Drug Administration. Last updated 2022 Jan 14. Accessed 2023 Feb 11. Available from: https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/ipledge-risk-evaluation-and-mitigation-strategy-rems.

5. A retrospective analysis of adherence to risk evaluation and mitigation strategies requirements for pulmonary arterial hypertension drugs;M Prokes;Hosp Pharm,2019

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