This guidance is intended to assist applicants in preparing the CLINICAL PHARMACOLOGY section of prescription drug labeling (henceforth referred to as labeling) to meet regulatory requirements and ensure appropriate consistency in the format and content of this section for all prescription drugs approved by FDA.
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.