Regulation Brief October 14, 2026, 2:00 PM ET

FDA launches Rare Disease Framework Initiative to gather public feedback

The FDA announced the Rare Disease Framework Initiative on October 14, 2026, aiming to create a fit-for-purpose framework for rare disease drug development. It will host an October 28 meeting at its White Oak campus to solicit feedback from patients, advocates, and industry.

Primary source

FDA press announcement, October 14, 2026

FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development

Read the source: FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Development fda.gov

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