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PDUFA Negotiations Begin With FDA Seeking Review System Reform

This article was originally published in The Tan Sheet

Executive Summary

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.

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