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GUIDANCE DOCUMENT

Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products — Content and Format December 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2013-D-1067
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to assist applicants in developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). 2 The recommendations in this guidance are intended to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
 

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All written comments should be identified with this document's docket number: FDA-2013-D-1067.

 
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