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GUIDANCE DOCUMENT

Content and Format of the Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products March 2010

Final
Docket Number:
FDA-2007-D-0201
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Drug Evaluation and Research
Office of Medical Products and Tobacco, Center for Biologics Evaluation and Research

This guidance is intended to help applicants draft the DOSAGE AND ADMINISTRATION section of labeling required by 21 CFR 201.57(c)(3). 
 


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