FDA Office of Generic Drugs Issues 2016 Annual Report


Monitoring and Reporting Working Group

On February 28, 2017, FDA’s Office of Generic Drugs (OGD) posted its 2016 annual report.  The report discusses Generic Drug User Fee Amendments (GDUFA), guidances and standards, enhancing communication with industry and stakeholders, approval and other regulatory actions, and 2016 GDUFA Regulatory Science Plan.

2016 marked the highest number of generic drug approvals and tentative approvals ever awarded by OGD (more than 800).  OGD continues to improve its review infrastructure, meet all Generic Drug User Fee Amendments (GDUFA) commitments, and promote consistency across all applications.  OGD has also begun leveraging international generic drug activities to better understand drivers of the global drug market, which is critical to ensuring consistent quality in generic drugs sold in the U.S.  OGD began to engage with FDA’s Office of International Programs and CDER’s Office of Strategic Planning, to better work with FDA international offices, regional regulators, and foreign industry in India, China, and Latin America.  OGD also developed programs for working with ICH on regulation, manufacturing, and inspection for several aspects of generic drug application and review.  OGD is also exploring how to best work with other international organizations, such as the International Generic Drug Regulators Progamme.

2016 OGD Highlights:

  • Approved 630 abbreviated new drug applications (ANDAs) and tentatively approved 183—the highest number of generic drug approvals and tentative approvals in the history of the generic drug program.
  • Met required GDUFA review timeframes.
  • Published more than 200 product-specific guidances related to developing generic drugs, for a total of more than 1,500 posted on FDA’s website.
  • Issued first approvals for generic versions of commonly used drugs including Benicar, Viagra, Crestor, and Tamiflu.
  • Awarded funding to 16 new external researchers to conduct regulatory science activities that will complement FDA’s research efforts.
  • Supported 87 ongoing external research collaborations.
  • Verified validity of FDA’s bioequivalence standards for certain drugs through scientific studies, demonstrating the proven efficacy and safety of generic drugs.