Overview of FDA guidelines for patient engagement in medical product development and regulatory decision making
About 10 years ago, the FDA launched an initiative to expand the role of patients in informing regulators and sponsors about the most serious consequences of the disease and the main treatment goals that can lead to desired medical outcomes. This initiative has grown into four guidance that aim.
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| Main Authors: | V. G. Borovskaya, A. R. Kasimova |
|---|---|
| Format: | Article |
| Language: | Russian |
| Published: |
Publishing House OKI
2023-08-01
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| Series: | Реальная клиническая практика: данные и доказательства |
| Subjects: | |
| Online Access: | https://www.myrwd.ru/jour/article/view/36 |
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