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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User Fee Bill’s Accelerated Approval Reform Provisions Watered Down, But Could Speed Withdrawals
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.
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.
US FDA’s Accelerated Approval Reforms Include Dispute Resolution For Withdrawals
Allowing decisions to be reviewed by higher management levels, rather than convening administrative hearings, could save time in the withdrawal process.