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2013-10-23
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Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability
Notices
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D09002ee1bdc94a6f
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 guidance for industry <greek-i>188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this guidance is to assist sponsors or non-applicants with filling out Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report,'' in both paper and electronic format, as required by FDA regulations.
78 FR 63221
https://www.govinfo.gov/app/details/FR-2013-10-23/2013-24803
2013-24803
fr23oc13-87
4160-01-P
Docket No. FDA-2010-D-0241
https://www.govinfo.gov/app/details/FR-2013-10-23/2013-24803
https://www.govinfo.gov/content/pkg/FR-2013-10-23/html/2013-24803.htm
https://www.govinfo.gov/content/pkg/FR-2013-10-23/pdf/2013-24803.pdf
1 p.
63221
63221
78 FR 63221
Guidance for Industry on Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine; Availability; Federal Register Vol. 78, Issue
NOTICE
2013-24803
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2010-D-0241
4160-01-P
2013-24803
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry <greek-i>188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this guidance is to assist sponsors or non-applicants with filling out Form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report,'' in both paper and electronic format, as required by FDA regulations.
Submit either electronic or written comments on Agency guidances at any time.
Margarita Brown, Center for Veterinary Medicine (HFV-241), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9048. margarita.brown@fda.hhs.gov.
Guidance for Industry; Availability:
Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine
,
margarita.brown@fda.hhs.gov
http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 205
Office of the Federal Register, National Archives and Records Administration
2013-10-23
continuing
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424 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2013-10-23
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0042-1219
0364-1406
769-004-00000-9
000582072
f:fr23oc13
https://www.govinfo.gov/app/details/FR-2013-10-23
https://www.govinfo.gov/content/pkg/FR-2013-10-23/pdf/FR-2013-10-23.pdf
https://www.govinfo.gov/content/pkg/FR-2013-10-23/xml/FR-2013-10-23.xml
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