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Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
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Summary (from the Federal Register abstract)
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of additional draft and 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 type
- Notice
- Federal Register document number
- 2026-03963
- Published
- Feb 27, 2026
- Action
- Notice of availability.
- Docket
- FDA-2007-D-0369
- Comments posted on Regulations.gov (at last check)
- 0
- DATES section (from the document)
- Submit either electronic or written comments on the draft guidance by April 28, 2026 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
- Topics (auto-tagged)
- CMC (chemistry, manufacturing & controls)
Source: Federal Register API, document 2026-03963. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.