Today, the 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, thereby helping to streamline generic drug product development by industry and ANDA assessment by the FDA.
Today’s batch of 36 PSGs includes:
- 19 new and 17 revised PSGs
- PSGs for generic products for important treatments for diseases such as:
o Human Immunodeficiency Virus (HIV)
o Prostate Cancer
o Helicobacter Pylori Infection
- 27 PSGs for products with no approved ANDAs (including 6 for complex products)
- PSGs for complex products (3 new and 6 revised PSGs)
o 2 of these PSGs were developed based on research data generated by the Generic Drug User Fee Amendments (GDUFA)-funded Science and Research program
Of note, the FDA is revising the PSG on liposomal amphotericin B injection, an antifungal used to treat fungal infections, based on new safety information and results from GDUFA-funded Science and Research projects. First, the revised PSG recommends that a bioequivalence (BE) study can be done in healthy subjects rather than in the patient population, simplifying the in vivo BE study design and subject recruitment. Second, data on free (liposome-unbound) amphotericin B can be used as supportive evidence instead of pivotal evidence to establish BE, which improves the efficiency and flexibility of the in vivo BE study. Both changes are possible because GDUFA-funded research enabled the development of two new in vitro BE studies for evaluating potential formulation differences. These changes in recommendations may facilitate generic drug development and improve study performance.
When finalized, these guidances will describe the agency’s current thinking and expectations 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.
The FDA aims to ensure that policies, regulations, and scientific standards keep pace with the science of equivalence. Improving patient access to high quality and affordable medicines supports the agency’s mission to advance the public health.
FDA publishes PSGs to facilitate generic drug development by helping potential applicants, especially for products that do not currently have approved generics, efficiently allocate product development resources and prepare more complete submissions. Once these products are developed and approved, generic competition for these drug products could support greater access to high-quality, potentially lower-cost, safe, and effective treatments.
Today, the 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 products as defined in our 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:
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