FDA CBER Phase 1 Fast-Track IND Pilot Opens Applications in September 2026; Up to 10 Programs Selected by Year End
The FDA Center for Biologics Evaluation and Research (CBER) confirmed Wednesday September 2, 2026 that the previously-announced Phase 1 fast-track IND pilot program is opening applications during September 2026, with up to 10 investigational programs selected by year end. The pilot follows the Center for Drug Evaluation and Research (CDER) parallel pilot announced earlier in 2026 and is designed to accelerate first-in-human clinical trial initiation for high-priority biologics (including cell and gene therapies, therapeutic vaccines, peptide-based biologics, and blood-derived products). The pilot matters for the peptide-industry pipeline because peptide-conjugate cancer vaccines, therapeutic peptide vaccines targeting infectious disease, and peptide-antimicrobial biologics all sit within the CBER regulatory scope and would benefit from the accelerated review timeline. Selection criteria emphasize unmet medical need, novel mechanism, and preclinical data quality; individual selection results will not be public.