FDA Announces Pilot for Orphan Designation Requests

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.

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