PDUFA Renewal Negotiations Nearly Complete, With CBER Slated For Major Resource Increase
While the prescription drug user fee agreement between industry and the US FDA is almost done, generic renewal talks remain ongoing, and biosimilar talks have not started.
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Accelerated Approvals Could Have Expiration Dates, Annual Reviews To Promote Confirmatory Trials, ICER Suggests
Institute for Clinical and Economic Review tackles reform of US FDA’s accelerated approval program in white paper responding to payer concerns about managing high-cost drugs supported by limited efficacy data and patient frustrations over possible access restrictions.
Mid-cycle meeting for some supplements cannot be accommodated without extending the goal date, the agency tells industry negotiators.
US FDA proposed increasing staffing and resources for both programs during the next user fee program cycle, but industry representatives did not believe it necessary.