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FDA Receives Assurances That PDUFA Remains Priority on Capitol Hill

Executive Summary

As Congress prepared to adjourn for summer recess without reauthorizing the Prescription Drug User Fee Act, FDA Commissioner Andrew von Eschenbach sent an e-mail to agency employees Aug. 3 designed to lessen worries about job security

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

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.

User Fees Collection Better Than Expected; Reserve Fund Could Lower FY '12 Fees

Manufacturer user fees paid for about 60% of FDA's drug review costs in fiscal year 2009.

Inspection Of Rx Imports Would Climb Under Bill Setting $300 Mil. In User Fees

Drug import fees totaling $300 million each in fiscal years 2008 through 2012 would be authorized by a food and drug import safety bill being developed by House Energy and Commerce Committee Chairman John Dingell, D-Mich

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