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FDA Publishes New Product-Specific Guidances to Facilitate Generic Drug Development

[8/21/2026] Today, the U.S. Food and Drug Administration published a new batch of draft product-specific guidances (PSGs) for developing generic drugs and generating evidence for abbreviated new drug applications (ANDAs).

FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to generic drugs that are as safe and effective as their brand name counterparts and meet the same high-quality standards. Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in our Drug Competition Action Plan.

This action advances the goals of the President’s Executive Order 14273, Lowering Drug Prices by Once Again Putting Americans First, accelerating the development and approval of generic drugs. 

Today’s batch of 55 PSGs contains:

  • More than 30 for products with no approved ANDAs, including 15 for complex products
  • 24 new and 31 revised
  • 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

When finalized, the PSGs in today’s batch will describe the agency’s current thinking and recommendations on how to develop generic drug products that are therapeutically equivalent to specific reference listed drugs. FDA considers all comments to the public docket before finalizing PSGs. 

Newly Updated – Upcoming PSGs 

Today, FDA also updated the “Upcoming Product-Specific Guidances for Generic Drug Product Development” web page, which includes new and revised PSGs under development and includes the planned revision categories and brief descriptions of the revisions.

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