PDUFA V Action Heats Up On Hill With House Hearings In February
This article was originally published in The Pink Sheet Daily
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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Preventing shortages through increased communications with manufacturers could gain the upper hand in part because creating economic incentives may prove too difficult and controversial.
While it would not grab as much attention as creating a whole new approval pathway, BIO believes tinkering with accelerated approval to give the regulations more clarity and increase its use still could generate the change it wants at FDA.