If you’ve finished reading War and Peace, I have another thriller for you to sink your teeth into.  The FY 2022 GDUFA Science and Research Report (here) provides 134 pages of interesting discussions on the OGD’s GDUFA research projects, the outcomes and benefits derived from the research initiatives as translated into Product Specific Guidances (PSGs) for complex products, and avenues for further research into topics of interest for the FDA and the generic drug industry, all in an effort to meet the challenges of new, innovative NDA products and the development pathways for follow-on generics.

The report notes that “[I]n FY 2022, FDA issued 177 new and revised PSGs (59 of which were for complex products) that provided recommendations for developing generic drugs and generating the evidence to support ANDA approval.  This included 117 PSGs for products (including 41 PSGs for complex products) with no approved ANDAs at the time of PSG publication.  Also, 18 PSGs were revised in FY 2022 to add an efficient in vitro BE option.”  Many of the guidances developed provide alternate, less burdensome methods of establishing bioequivalence through other than in vivo methods, using learning from the research conducted or funded by the GDUFA science and research program.  Others provide complex studies over long periods of time, but are certainly better than not having a pathway at all other than comparative bioequivalence studies with clinical endpoints.

The FY 2022 GDUFA Science and Research Report describes active and completed research projects and outcomes that are organized into thirteen scientific areas, which include:

  • Ophthalmic Products
  • Complex Mixtures and Peptide Products
  • Long-Acting Injectable, Insertable, or Implantable Products
  • Complex Injectables, Formulations, and Nanomaterials
  • Inhalation and Nasal Products
  • Topical Products
  • Locally-Acting Physiologically Based Pharmacokinetic Modeling
  • Quantitative Clinical Pharmacology
  • Oral Absorption Models and Bioequivalence
  • Patient Substitution of Generic Drugs
  • Abuse-Deterrent Opioid Drug Products
  • Data Analytics
  • Drug-Device Combination Products

The sections are rife with examples describing the practical implications of the research project, including approvals that have resulted from application of the research, along with links to PSGs that resulted from the same, as well as articles to reference for further insight.  I think that approaching this report should be like the proverbial answer to the question “How do you eat an elephant?”  “One bite at a time.”  Lots to learn in this report!  Enjoy!