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WebJan 30, 2024 · The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint. A surrogate ... WebJun 5, 2024 · The goal for priority review applications is 6 months. This review target is commonly referred to as the PDUFA goal date. However, FDA is currently experimenting with alternative review timelines (e.g., Real-Time Oncology Review pilot program) to provide patients with access to safe and effective therapies as soon as possible. … change disk file system from raw to ntfs
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