Accelerated Approval Reform Proposals Worry Industry: ‘Science Doesn’t Move The Same Way’
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.
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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.
Complete Response Letters: Industry Prefers Communication Before Rather Than Docs After
Rep. Dunn’s idea would be a return to prior agency practice; the documents are currently considered exempt from disclosure.
Decorating The 'Christmas Tree’: US House Bills That Could Be Tacked Onto FDA User Fee Legislation
Measures aimed at spurring biomedical innovation, ensuring fewer roadblocks to development of biosimilars and generics, and strengthening the FDA’s interactions with rare disease patients could find their way into must-pass legislation reauthorizing the human drug and biologic user fee programs by 30 September.