21 CFR Part 316 - Subpart C - Designation of an Orphan Drug
- § 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.