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, and Cosmetic Act, and provides intensive guidance on the designation process, including the criteria for eligibility and the process for rolling review and cross-disciplinary collaboration.
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: 3ea3e3a62242adf42cf1b42b3775c6f5101610ffbfa4c22ba338bf21466bb218
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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