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2015-09-19
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Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability
Notices
D09002ee1c184fd17
D09002ee1c184fda9
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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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 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 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 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.
80 FR 57000
https://www.govinfo.gov/app/details/FR-2015-09-21/2015-23571
2015-23571
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Docket No. FDA-2007-D-0369
https://www.govinfo.gov/app/details/FR-2015-09-21/2015-23571
https://www.govinfo.gov/content/pkg/FR-2015-09-21/html/2015-23571.htm
https://www.govinfo.gov/content/pkg/FR-2015-09-21/pdf/2015-23571.pdf
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80 FR 57000
Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability; Federal Register Vol. 80, Issue
NOTICE
2015-23571
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2007-D-0369
4164-01-P
2015-23571
Notice.
The Food and Drug Administration (FDA or Agency) 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 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 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.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments on these draft and revised draft guidances before it begins work on the final versions of the guidances, submit either electronic or written comments on the draft and revised draft product-specific BE recommendations listed in this notice by November 20, 2015.
Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301- 796-5850.
Guidance:
Product-Specific Bioequivalence Recommendations
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 80, no. 182
Office of the Federal Register, National Archives and Records Administration
2015-09-21
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185 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2015-09-21
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https://www.govinfo.gov/content/pkg/FR-2015-09-21/xml/FR-2015-09-21.xml
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