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2010-09-23
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Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
Notices
D09002ee1bdd87d1b
D09002ee1bdd87d8d
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product- specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
73 FR 51829
https://www.govinfo.gov/app/details/FR-2008-09-05/E8-20580
E8-20580
fr05se08-59
4160-01-S
Docket No. FDA-2007-D-0369
https://www.govinfo.gov/app/details/FR-2008-09-05/E8-20580
https://www.govinfo.gov/content/pkg/FR-2008-09-05/html/E8-20580.htm
https://www.govinfo.gov/content/pkg/FR-2008-09-05/pdf/E8-20580.pdf
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Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Federal Register Vol. 73, Issue
NOTICE
E8-20580
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2008-12-04
Docket No. FDA-2007-D-0369
4160-01-S
E8-20580
Notice.
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide product-specific guidance on the design of BE studies to support abbreviated new drug applications (ANDAs). In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry, ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product- specific BE recommendations available to the public on FDA's Web site. The BE recommendations identified in this notice were developed using the process described in that guidance.
Submit written or electronic comments on the draft product- specific BE recommendations listed in this notice by December 4, 2008.
Doan T. Nguyen, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9314.
Product-Specific Bioequivalence Recommendations; Publication of Guidances for Industry,
http://www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm
http://www.fda.gov/cder/guidance/index.htm
http://www.regulations.gov
Federal Register
Vol. 73, no. 173
Office of the Federal Register, National Archives and Records Administration
2008-09-05
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2008-09-05
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https://www.govinfo.gov/app/details/FR-2008-09-05
https://www.govinfo.gov/content/pkg/FR-2008-09-05/pdf/FR-2008-09-05.pdf
https://www.govinfo.gov/content/pkg/FR-2008-09-05/xml/FR-2008-09-05.xml
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