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FDA Commissioner Scott Gottlieb, M.D. announced last week new actions the FDA is taking to support and expedite development of rare disease products, including a new pilot for more efficient orphan designation requests.
A new fillable form will ease the submission process for sponsors completing designation requests, and increase the efficiency of FDA review. The FDA also launched a new online tutorial to guide sponsors through the orphan designation process.
May 7-11, 2024 | Baltimore, MD
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