Rare Disease Integration Into FDA Reviews Will Grow Under PDUFA VI
Stakeholders wonder about impact of placing orphan drug program staff "into review teams" as part of next iteration of user fee program.
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The group is intended to help rare disease drug developers answer all the necessary questions about surrogate endpoints and markers before the application review cycle.
The rival to House Energy and Commerce Committee Chair Frank Pallone’s bill would not set expiration dates for accelerated approvals.
If they reach a public disclosure agreement, a handful of sponsors will be admitted to a new pilot program that allows four meetings with the FDA on rare disease endpoint issues.