User Fee Legislation Revs Through Senate Mark-up, But House Bill Goes Back Into The Shop
Senate health committee defers action on several potentially contentious issues, with members hoping to resolve differences over FDA’s authorities on imports, shortages, foreign data and track-and-trace before the bill goes to the floor, possibly in May. Meanwhile, the House postpones its mark-up in an effort to craft a more bipartisan bill, and now will try to push the user fee package to the floor during an upcoming four-day marathon session.
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Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
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Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.