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2018-10-24
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Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Notices
D09002ee1bdbbe39d
D09002ee1bdbbe415
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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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 guidances, when finalized, 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 Web site. The guidances identified in this notice were developed using the process described in that guidance.
82 FR 32556
https://www.govinfo.gov/app/details/FR-2017-07-14/2017-14781
2017-14781
fr14jy17-63
4164-01-P
Docket No. FDA-2007-D-0369
https://www.govinfo.gov/app/details/FR-2017-07-14/2017-14781
https://www.govinfo.gov/content/pkg/FR-2017-07-14/html/2017-14781.htm
https://www.govinfo.gov/content/pkg/FR-2017-07-14/pdf/2017-14781.pdf
2 p.
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82 FR 32556
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability; Federal Register Vol. 82, Issue
NOTICE
2017-14781
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2007-D-0369
4164-01-P
2017-14781
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 guidances, when finalized, 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 Web site. The guidances 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 comment on a draft guidance announced in this notice before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 12, 2017.
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 Guidances; Draft and Revised Draft Guidances for Industry
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 134
Office of the Federal Register, National Archives and Records Administration
2017-07-14
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175 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2017-07-14
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https://www.govinfo.gov/app/details/FR-2017-07-14
https://www.govinfo.gov/content/pkg/FR-2017-07-14/pdf/FR-2017-07-14.pdf
https://www.govinfo.gov/content/pkg/FR-2017-07-14/xml/FR-2017-07-14.xml
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