Fight over user fees underscores bigger questions about US FDA's mission, Burrill report finds

23 May 2011

Industry frustration is growing over a failure to adequately fund the US Food and Drug Administration and ensure its commitment to review drugs in a timely manner as Congress crafts legislation to allow the agency to continue collecting fees from drugmakers to review their products.

Biotech 2011-Life Science: Looking Back to See Ahead, Burrill & Co's 25th annual report on the biotech industry examines the evolution of the Prescription Drug User Fee Act (PDUFA) and what's at stake for the industry, the FDA and patients in the emerging fight over the fifth incarnation of the legislation. The current version of the law is set to expire in September 2012.

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