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2011-03-15
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Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products; Availability
Notices
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D09002ee1bdd0d12b
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 entitled ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.'' The guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the guidance is to provide to industry considerations for developing plans for these types of emergencies, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.
76 FR 14025
https://www.govinfo.gov/app/details/FR-2011-03-15/2011-5949
2011-5949
fr15mr11-83
4160-01-P
Docket No. FDA-2009-D-0568
https://www.govinfo.gov/app/details/FR-2011-03-15/2011-5949
https://www.govinfo.gov/content/pkg/FR-2011-03-15/html/2011-5949.htm
https://www.govinfo.gov/content/pkg/FR-2011-03-15/pdf/2011-5949.pdf
2 p.
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76 FR 14025
Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products; Availability; Federal Register Vol. 76, Issue
NOTICE
2011-5949
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2009-D-0568
4160-01-P
2011-5949
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.'' The guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the guidance is to provide to industry considerations for developing plans for these types of emergencies, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.
Submit either electronic or written comments on Agency guidances at any time.
Thomas J. Christl, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 3358, Silver Spring, MD 20993-0002, 301- 796-2057.
Guidance for Industry; Availability:
Planning for Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 76, no. 50
Office of the Federal Register, National Archives and Records Administration
2011-03-15
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Table of Contents:
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AE 2.106:
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https://www.govinfo.gov/app/details/FR-2011-03-15
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https://www.govinfo.gov/app/details/FR-2011-03-15
https://www.govinfo.gov/content/pkg/FR-2011-03-15/pdf/FR-2011-03-15.pdf
https://www.govinfo.gov/content/pkg/FR-2011-03-15/xml/FR-2011-03-15.xml
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