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GUIDANCE DOCUMENT

Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format January 2006

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2005-D-0153
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance is intended to help applicants and reviewers in drafting the ADVERSE REACTIONS section of prescription drug labeling as required by 21 CFR 201.57(c)(7). Its primary purpose is to aid in (1) selecting information for inclusion in the section, (2) characterizing adverse reactions selected for inclusion, (3) organizing and presenting the information within the section, and (4) updating adverse reaction information. The goal of this guidance is to assist applicants in designing ADVERSE REACTIONS sections that contain the drug safety information important to patient management decisions and that convey the information in a clear and accessible format.

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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-2005-D-0153.

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