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Unapproved Drugs-Compliance Policy Guide, Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs

Unapproved Drugs-Compliance Policy Guide, Sec. 440.100 Marketed New Drugs Without Approved NDAs or ANDAs

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Published by: FDA Lawyers Blog on Sep 29, 2011
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09/29/2011

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Guidance for FDA Staff and
Industry
Marketed Unapproved Drugs –
Compliance Policy Guide
Sec. 440.100
Marketed New Drugs Without Approved NDAs or ANDAs
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
September 19, 2011
Compliance
 
 
Guidance for FDA Staff and
Industry
Marketed Unapproved Drugs
Compliance Policy Guide
Sec. 440.100
Marketed New Drugs Without
Approved NDAS or ANDAs
 Additional copies are available from:
Office of Communications
 Division of Drug Information, WO51, Room 2201
10903 New Hampshire Ave.
Silver Spring, MD 20993
Phone: 301-796-3400; Fax: 301-847-8714
druginfo@fda.hhs.gov
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation and Research (CDER)
September 19, 2011
Compliance

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