FDA Breakthrough Therapy Designation
Statutory
Description & Eligibility
US designation to expedite development and review of drugs showing substantial improvement over available therapy on a clinically significant endpoint.
Legal Reference / Source
FDASIA 2012, Section 902
FDA Breakthrough Therapy Designation
| Legal Status | Statutory |
| Source Ref. | FDASIA 2012, Section 902 |
| Countries | 0 countries |
Compliance Check
Legal Review7/24/2026
Global ValidityVerified