FDA Accelerated Approval For Rare Diseases Again Under Congressional Pressure

Letter being circulated by Rep. Bilirakis states the agency’s draft expedited approval guidance does not provide clarity for rare disease sponsors to use accelerated approval.

A rare disease advocate, unhappy with FDA’s draft guidance outlining accelerated approval, is rallying congressional support to push for changes in the final document.

The EveryLife Foundation for Rare Diseases said FDA’s draft guidance on expedited approval programs does not address rare disease needs and does not meet the congressional intent outlined in the...

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