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Regulatory Information
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2018-07-21
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Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability
Notices
D09002ee1c172b780
D09002ee1c172b88f
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 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 guidances identified in this notice were developed using the process described in that guidance.
83 FR 34851
https://www.govinfo.gov/app/details/FR-2018-07-23/2018-15735
2018-15735
fr23jy18-63
4164-01-P
Docket No. FDA-2007-D-0369
https://www.govinfo.gov/app/details/FR-2018-07-23/2018-15735
https://www.govinfo.gov/content/pkg/FR-2018-07-23/html/2018-15735.htm
https://www.govinfo.gov/content/pkg/FR-2018-07-23/pdf/2018-15735.pdf
3 p.
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83 FR 34851
Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-15735
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-09-21
Docket No. FDA-2007-D-0369
4164-01-P
2018-15735
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 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 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 September 21, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
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
,
https://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. 83, no. 141
Office of the Federal Register, National Archives and Records Administration
2018-07-23
continuing
daily
deposited
born digital
190 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-07-23
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https://www.govinfo.gov/app/details/FR-2018-07-23
https://www.govinfo.gov/content/pkg/FR-2018-07-23/pdf/FR-2018-07-23.pdf
https://www.govinfo.gov/content/pkg/FR-2018-07-23/xml/FR-2018-07-23.xml
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2018-07-21
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FR-2018-07-23
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