BioCentury

8:00 AM GMT, Dec 7, 2015
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Regulation

PDUFA priorities

FDA and the pharmaceutical and biotech industries have come to a consensus about the goals for PDUFA reauthorization: developing methods and practices to more comprehensively integrate patient perspectives into regulatory decisions, creating a scientific framework for collecting and interpreting real-world evidence and promoting the use of innovative clinical trial designs.

Regardless of the amount of money industry agrees to pay in user fees, FDA can only make progress on these goals if it overcomes its chronic inability to recruit, hire and retain sufficient numbers of qualified employees.

For the first time since the PDUFA program was created in 1992, FDA's review times and procedures are not a major focus of negotiations. The agency consistently meets or exceeds its review goals, and biopharma companies are happy with procedures created in PDUFA V for communications with review teams that

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This article and the information contained in BioCentury's publications and services are solely for your own personal, non-transferable licensed use and cannot be shared with any other individuals. For information about adding subscribers to your account or obtaining article reprints, please contact support@biocentury.com.