Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)

Pragmatic applications of implementation science frameworks to regulatory science: an assessment of FDA Risk Evaluation and Mitigation Strategies (REMS) (2014–2018)

Abstract Background A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program for certain medications with serious safety concerns required by the U.S. Food and Drug Administration (FDA) of manufacturers to implement to help ensure the benefits of the medication outweigh its risks. F...

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Bibliographic Details
Main Authors: Linda Huynh, Gita A. Toyserkani, Elaine H. Morrato
Format: Article
Language:English
Published: BMC 2021-08-01
Series:BMC Health Services Research
Subjects:
FDA
Drug safety
Risk Evaluation and Mitigation Strategies (REMS)
Assessment
RE-AIM
PRECEDE-PROCEED
Online Access:https://doi.org/10.1186/s12913-021-06808-3

Internet

https://doi.org/10.1186/s12913-021-06808-3

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