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2013-08-27
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Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability
Notices
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D09002ee1bdc9cb75
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.'' This draft guidance clarifies stability testing recommendations for abbreviated new drug applications (ANDAs) by providing responses to public comments in a questions-and-answers format. This draft guidance addresses public comments regarding FDA's recommendation to generic drug manufacturers to follow International Conference on Hamonisation (ICH) stability guidances Q1A (R2) through Q1E.
78 FR 52931
https://www.govinfo.gov/app/details/FR-2013-08-27/2013-20893
2013-20893
fr27au13-61
4160-01-P
Docket No. FDA-2012-D-0938
https://www.govinfo.gov/app/details/FR-2013-08-27/2013-20893
https://www.govinfo.gov/content/pkg/FR-2013-08-27/html/2013-20893.htm
https://www.govinfo.gov/content/pkg/FR-2013-08-27/pdf/2013-20893.pdf
2 p.
52931
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78 FR 52931
Draft Guidance for Industry on Abbreviated New Drug Applications: Stability Testing of Drug Substances and Products, Questions and Answers; Availability; Federal Register Vol. 78, Issue
NOTICE
2013-20893
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2012-D-0938
4160-01-P
2013-20893
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers.'' This draft guidance clarifies stability testing recommendations for abbreviated new drug applications (ANDAs) by providing responses to public comments in a questions-and-answers format. This draft guidance addresses public comments regarding FDA's recommendation to generic drug manufacturers to follow International Conference on Hamonisation (ICH) stability guidances Q1A (R2) through Q1E.
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 this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 28, 2013.
Radhika Rajagopalan, Center for Drug Evaluation and Research (HFD-640), Food and Drug Administration, 7500 Standish Pl., MPN2, Rm. 243, Rockville, MD 20855, 240-276-8546.
Draft Guidance for Industry; Availability:
Abbreviated New Drug Applications; Stability Testing of Drug Substances and Products, Questions and Answers
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm065005.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 166
Office of the Federal Register, National Archives and Records Administration
2013-08-27
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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-2013-08-27
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https://www.govinfo.gov/app/details/FR-2013-08-27
https://www.govinfo.gov/content/pkg/FR-2013-08-27/pdf/FR-2013-08-27.pdf
https://www.govinfo.gov/content/pkg/FR-2013-08-27/xml/FR-2013-08-27.xml
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