Lawmakers call on FDA to create more uniformity in rare disease drug reviews
A group of Democrats and Republicans from both the House and Senate recently sent a letter to FDA Commissioner Rob Califf requesting that the agency establish a task force to identify strengths and challenges for reviewing rare disease therapies and to publicly issue recommendations on better alignment across the agency.
The push comes as back in February, CBER director Peter Marks announced the upcoming launch of the next generation of Operation Warp Speed, which this time would take aim at rare diseases. FDA has granted more than 6,400 orphan designations since 1983, but still, the overwhelming majority of the more than 10,000 rare diseases afflicting Americans have no FDA-approved therapy.
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