A Proposed Framework for Patient-Focused Policy at the U.S. Food and Drug Administration
Medical product sponsors are encouraged to include the patient perspective in their medical product development strategy to inform product design, augment regulatory submissions, argue for alternative clinical trial designs, or to support indications in specific patient populations. The goal is to c...
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| Format: | Article |
| Language: | English |
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MDPI AG
2019-08-01
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| Series: | Biomedicines |
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| Online Access: | https://www.mdpi.com/2227-9059/7/3/64 |