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)).

 

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

 

 

Posted on the FDA website on 10 December 2014