Breaking News

Absorption Systems Registers as U.S. Generic Facility

March 27, 2013

Anticipates FDA registration for Panama ops

Absorption Systems has registered with the U.S. FDA as a generic drug facility under the Generic Drug User Fee Amendments of 2012 (GDUFA), which requires the company to be a Biopharmaceutics Classification System (BCS), bioequivalence (BE), and bioavailability (BA) testing facility. Additionally, the company’s Panama operation will be registered under GDUFA in the 2H13.
 
GDUFA authorizes the FDA to collect user fees from drug sponsors for marketing applications, NDAs for a branded drug, or ANDA for a generic drug. In exchange, a time limit is imposed on the agency's review of each application. Absorption Systems will not be charged a facility fee under GDUFA, since it is not involved in manufacturing of final dosage forms, APIs or primary packaging.
 
Patrick Dentinger, president and chief executive officer of Absorption Systems, said, "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."

blog comments powered by Disqus
  • Elemental Impurity Testing

    Elemental Impurity Testing

    Dr. Andrew Fussell, PANalytical ||January 28, 2016
    Advances in elemental impurity testing aid compliance with new USP requirements

  • Fit-For-Purpose Assay Development in Bioanalysis

    Fit-For-Purpose Assay Development in Bioanalysis

    Franklin Spriggs, Ligand Binding Assay Group Leader; Ashley Brant, Program Manager, AIT Bioscience||January 28, 2016
    The success of bioanalytical studies relies on the selection of the most suitable analytical method but the timeline of method development and types of analyses involved vary greatly.

  • CMOs: A Flexibility Alternative

    CMOs: A Flexibility Alternative

    Philip K. Burns, CRO-Consulting||January 28, 2016
    A look at how to include CMOs as an option to improve overall flexibility