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.
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:
Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.