FDA Publicizes Strategic Plan to Clear Bottleneck of Orphan Designation Requests

The FDA has about 200 orphan drug designation requests that are pending review and that number has been steadily rising over the past five years.

Recently, the FDA publicized its strategic plan to clear the bottleneck as part of its strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm deadlines.




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