The Office of Generic Drugs has published its 2022 Annual Report (here), outlining its accomplishments over the year.  As a reminder, this report has multiple sections and you can click on each section to see its contents once you are in the report; simply continue to scroll down until your fingers are tired.  It’s important to remember that this report is based on the calendar year, not the Fiscal Year (FY), and the figures will be obviously different if you look at the Generic Drugs Program Monthly and Quarterly Activities Reports, which are based on the FY.

The Program At‑A‑Glance section provides an overview of some of the important metrics from calendar year 2022, including facts that the OGD:

  • approved or tentatively approved 914 ANDAs (742 full approvals and 172 tentative approvals)
  • issued 1,775 Complete Response Letters (CRLs);
  • held 108 pre-ANDA meetings;
  • published 31 new policy documents;
  • issued 257 Product Specific Guidances (PSGs) (119 new and 138 revised); and
  • had 13,900 generic drugs stakeholders participate virtually in thirteen public workshops and one public forum.

The Highlights section discusses the finalization of the review and authorization for the GDUFA III program and all that came with the commitment letter for FY 2023 and beyond, as well as the following topics:

  • Scientific research to increase access to generic drugs;
  • International collaborations in which the OGD was involved; and
  • Regulatory Science Education efforts directed toward staff and external stakeholders.

The report is forty‑two pages chock full of information discussing everything generic‑drug related, from research to assuring data integrity in bioequivalence and application submissions, MaPPs and guidances, initiatives to support generic drug competition (more to come on this in FY 2023), and appendices to links for other helpful information and meeting summaries.  Keep this one by your nightstand for bedtime reading because, as busy as you are during the day, you might not have time to read it during working hours!