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

Issue Date: December 10, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Labeling
Status: Final

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

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.

Download the Guidance Document