21 CFR Subpart C
Designation of an Orphan Drug
June 25, 2020
§
316.20
Content and format of a request for orphan-drug designation
§
316.21
Verification of orphan-drug status
§
316.22
Permanent-resident agent for foreign sponsor
§
316.23
Timing of requests for orphan-drug designation; designation of already approved drugs
§
316.24
Deficiency letters and granting orphan-drug designation
§
316.25
Refusal to grant orphan-drug designation
§
316.26
Amendment to orphan-drug designation
§
316.27
Change in ownership of orphan-drug designation
§
316.28
Publication of orphan-drug designations
§
316.29
Revocation of orphan-drug designation
§
316.30
Annual reports of holder of orphan-drug designation
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