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PBOA Statement on Reauthorization of GDUFA

The Pharma & Biopharma Outsourcing Association (PBOA) lauded the news that the Food and Drug Administration (FDA) and industry have reached agreement on reauthorization of the Generic Drug User Fee Amendments (GDUFA) for a new five-year period, covering FY2018 to FY2022. PBOA was one of several industry groups that participated in GDUFA reauthorization negotiation sessions.

Gil Roth, President of the PBOA, remarked, “The PBOA hails the successful conclusion of the GDUFA II negotiation, and we believe that industry, the FDA and patients will see great benefits from the program during the next five-year period. PBOA’s presence at the negotiating table ensured that Contract Manufacturing Organizations (CMOs) were represented in the new iteration of this critical program. We look forward to working with the FDA and industry in the years ahead.”

GDUFA I was passed in 2012 as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) with the goals of improving safety, access and transparency within the generic sector. The new version of this industry-funded program, includes key improvements, metrics and resource provisions intended to streamline the review process for Abbreviated New Drug Applications (ANDAs), enhance FDA’s inspection infrastructure, and increase accountability, while providing relief for small businesses.

About the PBOA
Founded in 2014, the Pharma & Biopharma Outsourcing Association (PBOA) is a nonprofit trade association dedicated to advancing the regulatory, legislative and general business interests of Contract Manufacturing Organizations (CMOs) and Contract Development and Manufacturing Organizations (CDMOs). PBOA members provide the services that help the pharma and biopharma industry develop and manufacture drugs, biologics, vaccines, and other treatments safely and cost effectively. For more information about the PBOA, its members, and its mission, please visit www.pharma-bio.org. Follow us on Twitter at @PBOAssoc.

For more information:
Gil Roth
President, PBOA