Author: Site Editor Publish Time: 2026-09-18 Origin: Site
On August 21, 2026, the U.S. Food and Drug Administration (FDA) published a new batch of 55 draft Product-Specific Guidances (PSGs), providing product-level recommendations for generic drug development and the preparation of Abbreviated New Drug Applications (ANDAs).
The latest batch includes 24 new PSGs and 31 revised PSGs. Eighteen address complex generic drug products, including seven new and 11 revised guidances. In addition, more than 30 PSGs cover products with no approved ANDAs, including 15 complex products.
PSGs provide FDA's current recommendations for developing generic versions of specific reference listed drugs. Depending on the product, recommendations may address bioequivalence (BE) studies, in vitro testing, physicochemical characterization, and other supporting evidence.
By providing product-specific recommendations, PSGs can help generic drug developers identify appropriate development and evaluation strategies at an earlier stage, improving regulatory clarity and reducing uncertainty during development and ANDA preparation. FDA updates its PSGs as scientific and regulatory approaches evolve.
Complex generic products remain an important focus of FDA's ongoing regulatory science initiatives. The latest batch includes recommendations that further expand the use of in vitro BE studies and product characterization for certain complex products.
For example, the revised PSG for ferumoxytol injection includes new BE recommendations and additional physicochemical characterization tests. FDA also issued a new PSG for benzoyl peroxide/tretinoin topical cream, recommending in vitro BE studies and other characterization tests as an alternative approach to a comparative clinical endpoint BE study.
These developments illustrate the increasing role of product-specific, science-based evidence in the development of complex generics. For certain products, the regulatory pathway may incorporate multiple complementary forms of evidence rather than relying solely on traditional in vivo BE approaches.
For generic drug programs targeting the U.S. market, applicable PSGs should be reviewed during project selection and development planning, rather than only at the ANDA submission stage.
Understanding the latest FDA recommendations early can help developers align formulation development, analytical studies, BE strategy, and regulatory planning from the outset.
PSGs may be revised as FDA's scientific understanding and regulatory approaches evolve. For projects already in formulation development, in vitro testing, or BE studies, newly issued or revised PSGs should be assessed to determine whether existing development strategies remain aligned with the latest recommendations.
FDA also maintains an updated list of PSGs planned for development or revision over the coming year, providing an additional resource for generic drug developers to monitor upcoming regulatory changes.
For complex generic products, development increasingly requires coordination across formulation and process development, analytical characterization, in vitro BE, in vivo BE where applicable, and regulatory strategy.
Early alignment between technical development and regulatory requirements can help reduce the risk of major changes later in the development process.
The latest batch of 55 PSGs is notable not simply for the number of guidances published, but for the continued refinement of FDA's approach to product-specific development and complex generic evaluation.
For companies developing generic drugs for the U.S. market, particularly complex formulations, regulatory requirements should be incorporated into project selection, development strategy, study design, and regulatory planning from an early stage.
At Bestcomm Pharma, we continue to monitor developments in global pharmaceutical regulations and integrate relevant regulatory intelligence into pharmaceutical R&D and development planning. By connecting technical development with regulatory strategy, we aim to support our partners in developing efficient and commercially viable pharmaceutical products for global markets.
