Industry Willing To Let US FDA Go Slowly With Real-Time Review Expansion
Program growth beyond supplements will be determined after the agency gains experience with STAR program, PhRMA executive tells the Pink Sheet.
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Withdrawal procedure in House consensus bill would require only one advisory committee hearing, instead of potentially two, likely shortening the time to a final decision.
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.
Allowing decisions to be reviewed by higher management levels, rather than convening administrative hearings, could save time in the withdrawal process.