Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response
AbstractPurpose:Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as regulatory science tools. This mixed-methods evalu...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2019-08-01
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| Series: | Journal of Clinical and Translational Science |
| Subjects: | |
| Online Access: | https://www.cambridge.org/core/product/identifier/S205986611900400X/type/journal_article |