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.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.