FDA releases product-specific guidances for generic drug development

Today, FDA published a new batch of product-specific guidances (PSGs). PSGs provide recommendations for developing generic drugs and generating the evidence needed to support abbreviated new drug application (ANDA) approval, helping to streamline generic product development and ANDA assessment. FDA publishes PSGs to help facilitate generic drug competition, supporting greater access to safe, effective, and potentially lower cost treatments. Improving patient access to high-quality, affordable medicines supports the Agency’s mission to advance public health, as outlined in our Drug Competition Action Plan.

Today’s batch of 48 PSGs includes: 

• 29 new and 19 revised PSGs
• 28 PSGs for products with no approved ANDAs (16 non-complex and 12 complex products)
• 18 PSGs for complex products (9 new and 9 revised PSGs); 12 of these for products with no approved ANDAs (8 new PSGs)
• PSGs for products used for treatment of rare genetic diseases, HIV, severe hypoglycemia, and other conditions
• More than a dozen PSGs were supported by Generic Drug User Fee Amendments (GDUFA) science and research, such as:
  • Adult Periodontitis – FDA published a new PSG for doxycycline hyclate periodontal extended-release system 50 mg (RLD: Atridox, NDA 050751), which is the first PSG to recommend a totality of evidence-based in vitro approach for establishing bioequivalence (BE) of this poly (DL-lactide) (PLA)-based controlled release system. The in vitro BE approach is based on improved understanding of this type of delivery system, which was gained through multiple GDUFA research projects, and advancements in methods to sufficiently characterize the polymer and the formulation as well as reliably evaluate its drug release profile. The in vitro BE approach provides an alternate to the in vivo comparative clinical endpoints BE study, which can make the development of this product easier and more efficient while maintaining FDA’s high standards for quality and scientific rigor.

When finalized, the guidances in today’s batch posting 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 docket before finalizing PSGs.

Newly Updated – Upcoming Complex PSGs

Today, FDA also updated the Upcoming Product-Specific Guidances for Complex Generic Drug Product Development web page, which provides information about the agency’s plans for issuing new or revised PSGs in the coming year for complex generic drug products as defined in the GDUFA II Commitment Letter. This page is updated each time FDA publishes a new batch of PSGs.

For more information, to view the guidances, or to submit comments on the PSGs, visit the Federal Register Notice: Product-Specific Guidances

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