FDA Orphan Drug Designation
Statutory
Description & Eligibility
US designation for drugs treating rare diseases affecting fewer than 200,000 people, granting 7-year market exclusivity, tax credits, and fee waivers.
Legal Reference / Source
Orphan Drug Act 1983 (21 CFR 316)
FDA Orphan Drug Designation
| Legal Status | Statutory |
| Source Ref. | Orphan Drug Act 1983 (21 CFR 316) |
| Countries | 0 countries |
Compliance Check
Legal Review7/24/2026
Global ValidityVerified