1. Pink Sheet

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

 
• By Cathy Dombrowski

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.

The House Energy and Commerce Committee will waste no time in examining FDA’s user fee proposals, scheduling a Feb. 1 appearance by Commissioner Margaret Hamburg before the panel’s Health Subcommittee to discuss the fifth iteration of the Prescription Drug User Fee Act.

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