What Guidance for Industry: Breakthrough Therapies requires
The FDA Breakthrough Therapy Designation Guidance 2018 requires sponsors to submit a breakthrough therapy designation request, as outlined in Section 506(a) of the Federal Food, Drug…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.1 · Last updated:
Primary source: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy
SHA-256 integrity: a068277d2529292e4409432e3007b711e4fb5884b484c1342f207882e1cdab5d
Primary Citations — 5 traced to source
- Section 506(a) of the Federal Food, Drug, and Cosmetic Act: Breakthrough Therapy
- 21 CFR 312.80: Priority Review
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