PDUFA Likely to Stay, and Fee Hike Will go to Post-Market Safety | GenomeWeb

NEW YORK, March 7 - Biotech companies, including genomics-firms-cum-drug-discoverers, will get to keep the Prescription Drug User Fee Act, but it'll cost them a bit more than they're used to.

After seven months of back-room negotiations, the US Food and Drug Administration and the pharmaceutical and biotechnology industries have come to a provisional agreement on a new version of the popular act.

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