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FDA’s Fast Drug Approval Pathway Needs Revamp Soon, Califf Says

Oct. 17, 2022, 6:28 PM

The FDA’s accelerated drug approval process needs an update “as soon as possible” to address uncertainties about the risks and benefits of medications cleared through this pathway, agency chief Robert Califf said Monday.

“We need a system of evidence generation that provides a confirmation of benefits and the risk over the course of many years,” Food and Drug Administration Commissioner Califf said at the National Organization for Rare Disorders annual rare disease summit.

“While the process is intended to ensure the integrity of the data and analyses, the fact is that accelerated approvals based on biomarkers leave more uncertainty ...