United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2025_register executive 2025-05-21 article Notices D09002ee1d321e1ad D09002ee1d321e22d United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) 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. 90 FR 21778 https://www.govinfo.gov/app/details/FR-2025-05-21/2025-09068 2025-09068 fr21my25-53 4164-01-P Docket No. FDA-2007-D-0369 https://www.govinfo.gov/app/details/FR-2025-05-21/2025-09068 https://www.govinfo.gov/content/pkg/FR-2025-05-21/html/2025-09068.htm https://www.govinfo.gov/content/pkg/FR-2025-05-21/pdf/2025-09068.pdf 4 p. 21778 21781 90 FR 21778 Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability; Federal Register Vol. 90, Issue NOTICE 2025-09068 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2025-07-21 Docket No. FDA-2007-D-0369 4164-01-P 2025-09068 Notice of availability.

The Food and Drug Administration (FDA or Agency) 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.

Submit either electronic or written comments on the draft guidance by July 21, 2025 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. Joseph Kotsybar, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 3623A, Silver Spring, MD 20993-0002, 240- 402-1062, PSG-Questions@fda.hhs.gov. Guidance Draft and Revised Draft Product-Specific Guidances, PSG-Questions@fda.hhs.gov https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs https://www.fda.gov/regulatory-information/search-fda-guidance-documents https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 90, no. 97 Office of the Federal Register, National Archives and Records Administration 2025-05-21 continuing daily deposited born digital 160 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2025-05-21 P0b002ee1d321c022 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr21my25 https://www.govinfo.gov/app/details/FR-2025-05-21 https://www.govinfo.gov/content/pkg/FR-2025-05-21/pdf/FR-2025-05-21.pdf https://www.govinfo.gov/content/pkg/FR-2025-05-21/xml/FR-2025-05-21.xml fdlp 21685 21834 DGPO 2025-05-21 2025-05-21 FR-2025-05-21 machine generated eng FR FR-2025-05-21 90 97