The notice announces further revised draft guidances carrying product-specific recommendations, among them recommendations on the design of bioequivalence studies supporting abbreviated new drug applications.
Washington, 29 July 2026 — The Food and Drug Administration announced the availability of additional revised draft product-specific guidances. The notice states that the guidances provide product-specific recommendations on, among other things, the design of bioequivalence studies to support abbreviated new drug applications, and that they were developed using the process the agency described in a 2010 Federal Register notice.
Source documents
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Product-Specific Guidances; Revised Draft Guidances for Industry; Availability
- Identifier
- Federal Register document 2026-15285
- As the record states
- The Food and Drug Administration (FDA or Agency) is announcing the availability of additional revised draft product-specific guidances. The draft guidances provide product-specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
- Document number
- 2026-15285