August 3, 2017 – Ringwood, NJ – The Pharma & Biopharma Outsourcing Association (PBOA), a trade group that represents Contract Manufacturing Organizations (CMOs) and other service providers in the bio/pharmaceutical sector, is pleased that the U.S. Senate has unanimously consented to pass H.R. 2430, the FDA Reauthorization Act (FDARA). PBOA president Gil Roth issued the following statement:
“Our members commend the Senate for its passage of the FDA Reauthorization Act, including the Generic Drug User Fee Amendments. GDUFA II will not only empower FDA and industry to work toward swifter approval of cost-lowering generic drugs, it will also employ a fairer fee structure that better reflects the economic models of the various stakeholders. PBOA worked extensively with FDA and other industry groups to achieve those goals, and we are happy to see the program — along with three other major user fees — advance through the legislative process.
“PBOA applauds the bipartisan efforts of the Senate Health, Education, Labor and Pension (HELP) Committee and House Energy and Commerce Committee to bring FDARA through Congress, and we look forward to seeing it signed into law so that we can work with FDA and our peers to bring safe, effective medicines to patients.”
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 PBOA on Twitter at @PBOAssoc.
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