PDUFA V 'Program' First-Cycle Approval Rates Significantly Higher For All Applications
Success of review model for new molecular entities and novel biologics should bolster US FDA and industry's stance that Congress reauthorize the user fee program without tinkering with the negotiated agreement, which retains the 'Program' but builds in more flexibility.
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For Biosimilars, A Mid-Review Cycle Product Quality Discussion Appears To Be A Bad Omen
Only about one-third of biosimilars received a first-cycle approval from US FDA after product quality discussions during the mid-assessment-cycle meeting, according to an interim report on the biosimilar application review program.
House Appropriators Tip-Toe Into Biologics Transition Controversy
US FDA instructed to use the "Program" when assessing insulin applications with review goals before the 2020 transition date, but appropriations report does not explicitly urge elimination of the application "dead zone."
Complex Generic Mid-Cycle Meetings: US FDA Suggests Taking The Date Offered
US FDA offers best practices and tips to ensure successful meetings, although few have been conducted so far.