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提交患者经验数据时的现行做法和挑战 美国食品和药物管理局的监管决策:行业调查

Cathy Anne Pinto1, Tommi Tervonen2, Cecilia Jimenez-Moreno3

  • 1Merck & Co., Inc., Rahway, NJ, USA. cathy.pinto@merck.com.

The patient
|December 12, 2023
PubMed
概括

行业寻求更清晰的途径提交患者体验数据 (PED) 美国食品和药物管理局 (FDA). 关键需求包括透明的决策和扩大FDA关于在监管审查中使用PED的指导.

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