Rob Califf pledges 'high priority' accelerated approval reforms as Senate Finance chair backs his nomination at FDA
President Joe Biden’s choice to run the FDA has now promised Senate Finance Committee chair Ron Wyden (D-OR) that he will make reforms to the agency’s accelerated approval pathway “a high priority” if confirmed.
The issue, first raised by Wyden last week, concerns the FDA’s granting of more and more accelerated approvals, such as with Biogen’s new controversial Alzheimer’s drug, without confirming clinical benefit, and then the sponsors sometimes drag their feet for years beyond the FDA deadlines, occasionally even failing to complete the confirmatory trials required under the approvals.
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