OTP Town Hall: Best Practices for Regulatory Interactions with OTP
Office of Therapeutic Products, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration · July 23, 2026
FDA Office of Therapeutic Products hosted a virtual town hall answering sponsors' questions on formal meeting types, submission formats, designations, and best practices for IND/BLA interactions with OTP (CBER). Panelists reviewed timelines, documentation requirements, and communication tips for sponsors.
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