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12:00 AM
Dec 07, 2015
 |  BioCentury  |  Regulation

PDUFA priorities

Why FDA hiring key to PDUFA VI success

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 improve the predictability of reviews.

Real-world evidence

The agency and industry are honing plans to use PDUFA VI as a launchpad for putting into practice ideas that have been discussed for years, including using real-world evidence to make regulatory decisions. BIO and PhRMA are developing a proposal for FDA to work with industry and academic researchers on methods for using such evidence, including observational trials and electronic health records, to study efficacy. The hope is that these kinds of data could support label expansions.

The trade associations believe real-world evidence "likely has a role to play in augmenting or possibly replacing traditional data sources for benefit-risk decision making in the post-market setting," according to the public minutes from an Oct. 24 FDA-industry PDUFA meeting.

They want FDA to hold a public workshop, and then launch pilot...

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