The U.S. Senate has passed H.R. 2430, the FDA Reauthorization Act (FDARA). This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revises FDA user fees for new drug applications.
 
PBOA president Gil Roth said, “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.”
 
The Pharma & Biopharma Outsourcing Association (PBOA) is a trade group that represents Contract Manufacturing Organizations (CMOs) and other service providers in the bio/pharmaceutical sector.
 
“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,” Mr. Roth added.

Details of the bill, amended July 12th, can be found by clicking here, or follow the link below:

https://www.congress.gov/bill/115th-congress/house-bill/2430?q=%7B%22search%22%3A%5B%22H.R.+2430%22%5D%7D&r=1.