What We Expect the FDA to do in October and November 2025

By Alexander Gaffney, MS, RAC

Each fall, AgencyIQ publishes a forward-looking analysis outlining what the FDA is expected to do in the months ahead. This latest edition highlights the key regulatory catalysts shaping October and November 2025 — including new rulemakings, advisory committee meetings, user fee deadlines, and political developments likely to drive agency action.

From the potential release of long-awaited regulations to major deadlines under key user fee programs, this analysis helps regulatory professionals anticipate what’s next — and prepare their strategies accordingly.

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