21 CFR
Part 316 Orphan Drugs
Subpart A - General Provisions
Subpart B - Written Recommendations for Investigations of Orphan Drugs
- § 316.10 Content and format of a request for written recommendations
- § 316.12 Providing written recommendations
- § 316.14 Refusal to provide written recommendations
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
Subpart D - Orphan-drug Exclusive Approval
- § 316.31 Scope of orphan-drug exclusive approval
- § 316.34 FDA recognition of exclusive approval
- § 316.36 Insufficient quantities of orphan drugs