Absorption Systems Registers with FDA as a Generic Drug Facility under GDUFA
Self-identifies as a Biopharmaceutics Classification System (BCS), Bioequivalence, and Bioavailability Testing Facility
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GDUFA, which applies to generic drugs, is part of the 2012 renewal of the Prescription Drug User Fee Act (PDUFA), originally enacted in 1992 and renewed every five years thereafter.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.
Absorption Systems’ activities related to GDUFA involve classification of drug active ingredients according to the BCS. Part of the FDA drug approval pathway since 2000, the BCS classifies drugs according to the solubility and permeability of their active pharmaceutical ingredients (APIs). Absorption Systems is the world leader in the measurement of drug permeability for BCS classification. Drugs that meet the criteria for BCS Class I (high permeability and solubility) are eligible for a biowaiver, which simplifies the process of drug development.
Patrick Dentinger, President and CEO of Absorption Systems, commented that “The world is gradually realizing what a unique and reliable approach to accelerating product approval the BCS is. Whereas GDUFA is expected to reduce the backlog of generic reviews, the BCS eliminates unnecessary human testing and dramatically reduces both the time and cost of product approval.”
Collectively, these steps will benefit BCS adopters in the US and around the globe. The interest and growth in BCS applications have regulatory agencies around the world taking notice. With that in mind, Absorption Systems has expanded its support for the burgeoning pharmaceutical industry in Latin America by establishing its facility in Panama, in anticipation of increased demand for BCS-related studies.
About Absorption Systems
Absorption Systems, founded in 1996, assists pharmaceutical, biotechnology and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. The company’s mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. The CellPort Technologies(®) platform, a suite of human cell-based test systems for drug transporter characterization, exemplifies Absorption Systems’ commitment to innovation and is soon to be an industry assay standard for in vitro drug interaction assessment. Absorption Systems, with facilities near Philadelphia, PA, in San Diego, CA, and in Panama, serves customers throughout the world. For information on the company’s comprehensive contract services and applied research programs, please visit www.absorption.com.
SOURCE Absorption Systems