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PDUFA V Action Heats Up On Hill With House Hearings In February

This article was originally published in The Pink Sheet Daily

Executive Summary

An Energy and Commerce subcommittee will discuss the FDA and industry agreement on prescription drug user fees with FDA Commissioner Margaret Hamburg Feb. 1. Drug shortages will be part of the deliberations Feb. 7 when CDER Director Janet Woodcock goes before the panel to make the case for user fees on generic drugs and biosimilars.


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