The United States' House of Representative recently passed the authorization of the Prescription Drug User Fee Act (PDUFA). According to Jim Greenwood, President and CEO of Biotechnology Industry Organization (BIO), the new legislation, "will enhance and improve drug safety while providing the resources necessary for the Food and Drug Administration ("FDA") to continue the efficient and comprehensive review of new drugs and biologics". Resources will reduce review times for innovative drugs and biologics and provide patients and doctors with earlier access to breakthrough treatments.
The current PDUFA agreement is set to expire and if the new legislation is not passed by the Senate the FDA may be forced to reduce its work force.
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