Califf Says Accelerated Approval A ‘Different Objective’ And ‘Lower Hurdle’
The US FDA's comment came in response to a question about whether accelerated approval encourages sponsors to conduct lower-quality studies to enter the market.
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As a “laborious” hearing at the Food & Drug Administration on whether to withdraw the accelerated approval for Covis’s pre-term delivery drug Makena, FDA chief Robert Califf commented that industry is not doing enough to provide the evidence required for the fast-track approval pathway.
Allowing decisions to be reviewed by higher management levels, rather than convening administrative hearings, could save time in the withdrawal process.
During House hearing, PhRMA and BIO highlight provisions of PDUFA VII agreement that the associations say would benefit the pathway more than the additional reforms being considered by Congress.