Today, the FDA published 55 product specific guidances (PSGs) that provide FDA’s current bioequivalence recommendations for generic products. The PSGs can be found here and the current listing represents 24 new and 31 revised PSGs.

FDA says that today’s batch of 55 PSGs contain:

  • More than 30 for products with no approved ANDAs including 15 for complex products
  • 18 for complex products (7 new and 11 revised PSGs)

They address products such as:

  • Targeted oncology oral kinase inhibitors approved for specific types of non-small cell lung cancer (NSCLC), reflecting the agency’s continued advancement of precision oncology.
  • First-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, the first and currently only approved treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and adolescents, representing a breakthrough for a chronic lung disease with no prior FDA-approved therapies.
  • A poly (ADP-ribose) polymerase (PARP) inhibitor representing a pioneering approval, particularly for BRCA-mutated cancers, helping establish regulatory framework for biomarker-driven cancer therapies.

This batch includes guidance that addresses products supported by GDUFA-funded research, such as:

  • Revised PSG for ferumoxytol injection (FERABRIGHT, NDA 219868), including new bioequivalence recommendations along with additional physicochemical characterization tests to support approval.
  • New PSG for benzoyl peroxide; tretinoin topical cream (TWYNEO, NDA 214902) recommending in vitro bioequivalence studies and other characterization tests as an alternative option to a comparative clinical endpoint bioequivalence study.

Scan the list of new and revised PSGs carefully to assure FDA that your development program is in line with FDA’s recommendations and if not, you should contact FDA to discuss the acceptability of your plan. If you already have a product approved or an application pending before the Agency, and there was a PSG revision that changes the FDA’s thinking regarding the requirements for establishing bioequivalence, you should contact FDA to determine the impact (if any), it may have on your pending application or marketed drug product.