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Posted 22 March 2012 | By Alexander Gaffney, RAC
The first hearing in the US Senate for the Prescription Drug User Fee Act (PDUFA) reauthorization has been scheduled for next week.
The Senate Committee on Health, Education, Labor and Pensions' (HELP Committee) will meet on 29 March 2012 at 10:00 AM EST to discuss the act, which is requires renewal by the end of the year.
Witnesses for the hearing have not yet been announced.
The user fee legislation is on a fairly tight deadline, as Regulatory Focus reported in January. Due to an election-year calendar cycle in which many Senators and Representatives travel back to their home districts to campaign or attend national political conventions, the majority of the work on the bill needs to be done in the next few months.
Senate HELP Committee - FDA User Fee Agreements: Strengthening FDA and the Medical Products Industry for the Benefit of Patients
Regulatory Focus - PDUFA Hearings Highlight Support and Concerns About Legislation
Regulatory Focus - PDUFA Draft Makes Changes to FDA Mission, Regulatory Pathways
Tags: Deadline, HELP Committee, Testimony, Hearing, Latest News, HELP, PDUFA
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This article provides a variety of websites with important information on recent changes to FDA guidances and tables ...