Details on PDUFA, FDA reform agendas

WASHINGTON The biotech and pharmaceutical industries last week provided Congress with proposals worked out with the FDA for the reauthorization of the Prescription Drug User Fee Act (PDUFA), as well as a 20-page outline of targets for legislative intervention where the industry and the agency have been unable agree on the broader issues of FDA modernization.

Representing both the Biotechnology Industry Organization and the Pharmaceutical Research and Manufacturers of America, Amgen Inc. Chairman and CEO Gordon Binder told the Senate Labor and Human Resources Committee that industry is not asking Congress to go beyond the reforms outlined by BIO and PhRMA.

Specifically, he said the trade associations are not seeking legislative "hammers" punitive sanctions for FDA’s failure to comply with deadlines that were

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