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...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMC
2021-08-01
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| Series: | BMC Health Services Research |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12913-021-06808-3 |