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GUIDANCE DOCUMENT

Clinical Studies Section of Labeling for Human Prescription Drug and Biological Products — Content and Format Guidance for Industry January 2006

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2000-D-0074
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 deciding (1) what studies should be included in the CLINICAL STUDIES section of prescription drug labeling, (2) how to describe individual studies, and (3) how to present study data, including presentation of data in graphs and tables. This guidance is intended to make the CLINICAL STUDIES section of labeling, as described in the final rule amending the requirements for the content and format of labeling for human prescription drug and biological products (21 CFR 201.56 and 201.57), more useful, and to promote consistency in the content and format of the section across drug product classes and within drug classes and indications. This guidance also calls attention to the advertising and promotional implications of data and statements contained in the CLINICAL STUDIES section. 

The principal objective of labeling is to provide the information that is most useful to prescribers in treating their patients.  In some cases, making the information in the CLINICAL STUDIES section of labeling more useful to prescribers could warrant significant departures from past labeling practices.

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2000-D-0074.

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