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Time for Transparency: PDUFA V’s Big “Experiment”

This article was originally published in RPM Report

Executive Summary

Industry came to the PDUFA V negotiating table with one big agenda item: improved communication with FDA officials about a product under review. They succeeded, but it came with a price: an extra two months for FDA to review an application. While it may seem like things just went back to 2002, both industry and the agency say it could actually lead to faster approvals.

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