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2014-06-12
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Draft Guidance for Industry on Abbreviated New Drug Application Submissions; Content and Format of Abbreviated New Drug Applications; Availability
Notices
D09002ee1bdc418ec
D09002ee1bdc4198c
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Content and Format of Abbreviated New Drug Applications.'' The guidance document is intended to assist applicants in preparing complete and high-quality original abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug, and Cosmetic Act. The guidance summarizes the statutory and regulatory requirements for ANDAs, references existing guidance documents, and incorporates additional recommendations on the content and format of ANDA submissions. This guidance describes the Common Technical Document format for human pharmaceutical product applications and specifies the information to be submitted in each section of the application.
79 FR 33758
https://www.govinfo.gov/app/details/FR-2014-06-12/2014-13641
2014-13641
fr12jn14-67
4160-01-P
Docket No. FDA-2014-D-0725
https://www.govinfo.gov/app/details/FR-2014-06-12/2014-13641
https://www.govinfo.gov/content/pkg/FR-2014-06-12/html/2014-13641.htm
https://www.govinfo.gov/content/pkg/FR-2014-06-12/pdf/2014-13641.pdf
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79 FR 33758
Draft Guidance for Industry on Abbreviated New Drug Application Submissions; Content and Format of Abbreviated New Drug Applications; Availability; Federal Register Vol. 79, Issue
NOTICE
2014-13641
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-0725
4160-01-P
2014-13641
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``ANDA Submissions--Content and Format of Abbreviated New Drug Applications.'' The guidance document is intended to assist applicants in preparing complete and high-quality original abbreviated new drug applications (ANDAs) for submission to FDA under the Federal Food, Drug, and Cosmetic Act. The guidance summarizes the statutory and regulatory requirements for ANDAs, references existing guidance documents, and incorporates additional recommendations on the content and format of ANDA submissions. This guidance describes the Common Technical Document format for human pharmaceutical product applications and specifies the information to be submitted in each section of the application.
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 August 11, 2014.
Elizabeth Giaquinto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 1670, Silver Spring, MD 20993-0002, 240- 402-7930, email: elizabeth.giaquinto@fda.hhs.gov, or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268, Silver Spring, MD 20993-0002, 240-402-7911.
Draft Guidance for Industry:
Content and Format of Abbreviated New Drug Applications
,
elizabeth.giaquinto@fda.hhs.gov
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 79, no. 113
Office of the Federal Register, National Archives and Records Administration
2014-06-12
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2014-06-12
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https://www.govinfo.gov/app/details/FR-2014-06-12
https://www.govinfo.gov/content/pkg/FR-2014-06-12/pdf/FR-2014-06-12.pdf
https://www.govinfo.gov/content/pkg/FR-2014-06-12/xml/FR-2014-06-12.xml
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