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US law
Federal (United States)
Regulations
Title 21 CFR — Food and Drugs
Chapter I — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
Part 316 — ORPHAN DRUGS
Subpart D — Orphan-drug Exclusive Approval
Federal (United States) · Regulations
Subpart D — Orphan-drug Exclusive Approval
3 sections
3 sections
21 C.F.R. § 316.31
Scope of orphan-drug exclusive approval.
21 C.F.R. § 316.34
FDA recognition of exclusive approval.
21 C.F.R. § 316.36
Insufficient quantities of orphan drugs.
Subpart D — Orphan-drug Exclusive Approval | Federal (United States) Regulations | Justis AI