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Article: Survey Points To PDUFA As Reason For Low FDA Morale.
- Article from:
- BIOWORLD Today
- Article date:
- November 3, 2009
CopyrightCOPYRIGHT 2009 A Thomson Healthcare Company. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Washington Editor
WASHINGTON - Internal dissatisfaction is mounting at the FDA, according to a newly released survey, and the agency's user-fee system seems to have a big role in its off-putting atmosphere.
"Concerns about the user-fee programs were not surprising," Susan Wood, a former high-ranking FDA official, told BioWorld Today. Survey respondents indicated multiple deleterious consequences of the Prescription Drug User Fee Act (PDUFA) and similar laws, which overall these days account for nearly a fifth of the FDA's annual budget.
First, Wood pointed to frustration among FDA staff who feel pressure working under the laws' review-time ...