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PDUFA V Heading Toward Congressional Playing Field

By Mari Serebrov
Washington Editor

Wednesday, October 26, 2011

WASHINGTON – As the ball for the reauthorization of PDUFA bounces toward the congressional court, biopharma is keeping its fingers crossed that Congress doesn't interfere with the rules of the game that the FDA negotiated with industry over the past year.

In urging Congress to act quickly to reauthorize PDUFA, the Pharmaceutical Research and Manufacturers of America (PhRMA) asked lawmakers to refrain from adding provisions that could delay the legislative process or create excessive regulatory burdens or uncertainty for the FDA, industry and other stakeholders.

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