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2010-08-17
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Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Small Entity Compliance Guide; Availability
Notices
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United States
Department of Health and Human Services
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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 small business entities entitled ``Organ Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use--Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with FDA's regulation entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Final Monograph'' (74 FR 19385, April 29, 2009).\1\ The guidance describes the organ-specific labeling requirements in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act. ---------------------------------------------------------------------------
75 FR 50770
https://www.govinfo.gov/app/details/FR-2010-08-17/2010-20252
2010-20252
FR17AU10-59
4160-01-S
Docket No. FDA-2010-D-0404
https://www.govinfo.gov/app/details/FR-2010-08-17/2010-20252
https://www.govinfo.gov/content/pkg/FR-2010-08-17/html/2010-20252.htm
https://www.govinfo.gov/content/pkg/FR-2010-08-17/pdf/2010-20252.pdf
1 p.
50770
50770
75 FR 50770
Guidance for Industry on Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use-Small Entity Compliance Guide; Availability; Federal Register Vol. 75, Issue
NOTICE
2010-20252
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2010-D-0404
4160-01-S
2010-20252
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for small business entities entitled ``Organ Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use--Small Entity Compliance Guide.'' This guidance is intended to help small businesses understand and comply with FDA's regulation entitled ``Organ-Specific Warnings: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use; Final Monograph'' (74 FR 19385, April 29, 2009).\1\ The guidance describes the organ-specific labeling requirements in plain language and provides answers to common questions on how to comply with the rule. This guidance was prepared in accordance with the Small Business Regulatory Fairness Act. ---------------------------------------------------------------------------
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Arlene Solbeck, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5426, Silver Spring, MD 20993-0002, 301- 796-2090.
Guidance for Industry on Organ-Specific Warnings:
Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human UseSmall Entity Compliance Guide; Availability
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http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
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Federal Register
Vol. 75, no. 158
Office of the Federal Register, National Archives and Records Administration
2010-08-17
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https://www.govinfo.gov/app/details/FR-2010-08-17
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https://www.govinfo.gov/app/details/FR-2010-08-17
https://www.govinfo.gov/content/pkg/FR-2010-08-17/pdf/FR-2010-08-17.pdf
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2010-08-17
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