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FDA Annual Reports – New Drug Therapy Approvals (First‑in‑Class, Orphan, Fast Track, Breakthrough, Priority Review, etc.)
FDA Annual Reports – New Drug Therapy Approvals (First‑in‑Class, Orphan, Fast Track, Breakthrough, Priority Review, etc.)
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Original Request Contents: Request annual reports for new drug therapy approvals for First-in-Class, Orphan, Fast Track, Breakthrough Therapy, Priority Review, Accelerated Approval, PDUFA Goal Met, First Cycle Approval, and First in the United States
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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