FDA Draft Guidance: Patient Counseling Information Section of Labeling
This guidance document is being distributed for comment purposes only.
This guidance is intended to assist applicants with developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). 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.This guidance is intended to assist applicants with the following:
- How to decide what topics to include in the PATIENT COUNSELING INFORMATION section
- How to present information in the PATIENT COUNSELING INFORMATION section
- How to organize the PATIENT COUNSELING INFORMATION section
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.