Federal (United States) · Regulations
Subpart C — Designation of an Orphan Drug
11 sections
11 sections
- 21 C.F.R. § 316.20Content and format of a request for orphan-drug designation.
- 21 C.F.R. § 316.21Verification of orphan-drug status.
- 21 C.F.R. § 316.22Permanent-resident agent for foreign sponsor.
- 21 C.F.R. § 316.23Timing of requests for orphan-drug designation; designation of already approved drugs.
- 21 C.F.R. § 316.24Deficiency letters and granting orphan-drug designation.
- 21 C.F.R. § 316.25Refusal to grant orphan-drug designation.
- 21 C.F.R. § 316.26Amendment to orphan-drug designation.
- 21 C.F.R. § 316.27Change in ownership of orphan-drug designation.
- 21 C.F.R. § 316.28Publication of orphan-drug designations.
- 21 C.F.R. § 316.29Revocation of orphan-drug designation.
- 21 C.F.R. § 316.30Annual reports of holder of orphan-drug designation.