Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM

Adaptation for Regulatory Application: A Content Analysis of FDA Risk Evaluation and Mitigation Strategies Assessment Plans (2014–2018) Using RE-AIM

Background: Risk Evaluation and Mitigation Strategies (REMS) are safety programs that U.S. Food and Drug Administration can require to ensure a drug's benefits outweigh its risks and can be considered public health interventions. FDA's 2019 draft Guidance for Industry on REMS Assessments e...

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Bibliographic Details
Main Authors: Gita A. Toyserkani, Linda Huynh, Elaine H. Morrato
Format: Article
Language:English
Published: Frontiers Media S.A. 2020-02-01
Series:Frontiers in Public Health
Subjects:
RE-AIM
REMS
FDA
risk management
regulatory science
drug safety
Online Access:https://www.frontiersin.org/article/10.3389/fpubh.2020.00043/full

Internet

https://www.frontiersin.org/article/10.3389/fpubh.2020.00043/full

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