FDA Forecast: What the FDA has Planned in 2026 for Pharmaceuticals and Biotechnology Products

What will the FDA do next year? Find out in this lively, fast-paced and forward-looking session - part of a long-running and popular Annual Convergence series – featuring experts in FDA regulation who lead the industry’s two most-read and -trusted regulatory policy and intelligence services.

The session will provide the audience with in-depth, specific and verifiable information about what the FDA is expected to do next year related to pharmaceuticals, biopharmaceuticals, cell and gene therapy, over-the-counter drugs, and generic drugs. We'll highlight specific regulations, guidance, policies, staff and trends that attendees can use to inform their regulatory strategies and monitoring in 2026.

This session, will provide session attendees with actionable information they can use to prepare for upcoming changes, understand how seemingly unrelated changes will intersect, identify catalyst events which may affect how the FDA regulates, and understand the priorities of key regulatory staff.