Health Law Daily Wrap Up, GENERIC DRUGS—NOTICES: FDA issues new and revised draft generic drug guidance recommendations, (Aug 27, 2026)

By WK Editorial Staff

FDA is seeking public comment on newly issued and revised draft product-specific guidances that outline recommended bioequivalence study approaches for generic versions of numerous prescription drug products.

The FDA announced the availability of 23 new draft and 25 revised draft product-specific guidances that provide recommendations for designing bioequivalence studies to support abbreviated new drug applications (ANDAs). The new and revised guidances cover a wide range of active ingredients, including products used to treat cardiovascular, dermatologic, hematologic, neurologic, and other conditions. FDA developed the guidances through its established product-specific guidance process, which allows stakeholders to review and comment on draft recommendations before the agency issues final versions. The agency is seeking public input on the draft guidances as part of its ongoing effort to provide recommendations for generic drug development and evaluation (Notice, 91 Fed. Reg. 54722 (Aug. 24, 2026)).

Dates. Submit either electronic or ‘written comments on these draft guidances by October 23, 2026 to ensure that the Agency considers your comment on these draft guidances before it begins work on the final version of these guidances.

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