Issue Date: January 24, 2006
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Final
Adverse Reactions Section of Labeling for Human Prescription Drug and Biological Products — Content and Format
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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