MedPage Today January 10, 2023
— Omnibus bill requires confirmatory trials of drug companies
Drugmakers will no longer be able to slow-walk their accelerated approvals to full regulatory approval, said FDA Commissioner Robert Califf, MD, during the J.P. Morgan Healthcare Conference on Tuesday, while also fielding questions on gene therapies and the modernization of clinical trials, among other topics.
Accelerated Approval
When asked about the kind of data needed to warrant an accelerated approval decision, Califf said it would depend on the clinical condition and what other treatments are available.
Criteria for accelerated approvals are already “pretty well laid-out,” he noted, but there has been one “big change.” A provision of the Inflation Reduction Act now requires companies to “move quickly to either verify or...
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