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2011-10-14
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Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability
Notices
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D09002ee1bdce8ef5
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) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and Boxed Warning'' sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
76 FR 63303
https://www.govinfo.gov/app/details/FR-2011-10-12/2011-26297
2011-26297
fr12oc11-79
4160-01-P
Docket No. FDA-2011-D-0694
https://www.govinfo.gov/app/details/FR-2011-10-12/2011-26297
https://www.govinfo.gov/content/pkg/FR-2011-10-12/html/2011-26297.htm
https://www.govinfo.gov/content/pkg/FR-2011-10-12/pdf/2011-26297.pdf
2 p.
63303
63304
76 FR 63303
Guidance for Industry on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products-Content and Format; Availability; Federal Register Vol. 76, Issue
NOTICE
2011-26297
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-D-0694
4160-01-P
2011-26297
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drug and Biological Products--Content and Format.'' This guidance is intended to assist applicants and reviewers in drafting the ``Warnings and Precautions, Contraindications, and Boxed Warning'' sections of labeling for human prescription drug and biological products. The recommendations in this guidance will help ensure that the labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
Submit either electronic or written comments on Agency guidances at any time.
Cheryl Grandinetti, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3244, Silver Spring, MD 20993-0002, 301- 796-3516; or
Guidance for Industry; Availability:
Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Human Prescription Drugs, etc.
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 76, no. 197
Office of the Federal Register, National Archives and Records Administration
2011-10-12
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396 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2011-10-12
P0b002ee180e7ad60
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr12oc11
https://www.govinfo.gov/app/details/FR-2011-10-12
https://www.govinfo.gov/content/pkg/FR-2011-10-12/pdf/FR-2011-10-12.pdf
https://www.govinfo.gov/content/pkg/FR-2011-10-12/xml/FR-2011-10-12.xml
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2011-10-14
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FR-2011-10-12
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FR-2011-10-12
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