Absorption Systems Registers With FDA As A Generic Drug Facility Under GDUFA
EXTON, Pa., March 25, 2013 /PRNewswire/ -- The preclinical contract research organization Absorption Systems, a global leader in pharmacokinetic testing of drugs and the world leader in the in-vitro classification of drugs according to the Biopharmaceutics Classification System (BCS), announces that it has registered with the United States Food and Drug Administration (FDA) as a generic drug facility under the Generic Drug User Fee Amendments of 2012 (GDUFA). As required by GDUFA, the company self-identified as a BCS, bioequivalence (BE), and bioavailability (BA) testing facility and is now on the FDA's list of registered facilities. In addition, to take advantage of the emerging markets of Central and South America, Absorption Systems' Panama operation will be registered with the FDA as a generic drug facility under GDUFA in the second half of 2013. Central and South America will benefit tremendously from the regional presence of an established leader in the field of BCS, BE and BA.
GDUFA, which applies to generic drugs, is part of the 2012 renewal of the Prescription Drug User Fee Act (PDUFA), originally enacted in 1992 and renewed every five years thereafter. Both authorize the FDA to collect user fees from drug sponsors at the time of submission of a marketing application: new drug application (NDA) for a proprietary, branded drug or abbreviated new drug application (ANDA) for a generic drug. In exchange, a time limit is imposed on the agency's review of each application. PDUFA is credited with greatly improving the efficiency of new drug reviews by the FDA; the average review time for priority drugs has dropped from 24 months in 1992 (pre-PDUFA) to 13 months in 2012. GDUFA is expected to help reduce the current backlog of generic drug reviews, which is due to the increase in the number of generic drug applications, their growing complexity, and the need to inspect the growing number of generic drug facilities located overseas.
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