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PDUFA Negotiations Begin With FDA Seeking Review System Reform

 
• By Derrick Gingery

During the inaugural negotiating session for renewal of PDUFA, which covers OTC switch and other nonprescription product NDAs, FDA says among its goals are “enhancements to the review processes.” The five-hour session included the ground rules for the talks and FDA and industry representatives also laid out their general wants and needs.

FDA looks to make more changes to the application review system as part of the prescription drug user fee program reauthorization process.

During the inaugural negotiating session for renewal of the program, the agency said that among its goals for PDUFA VI are “enhancements to the review processes,” according to the

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