This guidance is intended to assist sponsors of new drug applications (NDAs) with the development of drug products that treat or help prevent gingivitis in adults and children. This document defines gingivitis and clarifies the distinction between gingivitis and periodontitis. It discusses general issues such as over-the-counter (OTC) versus prescription status and prevention versus treatment. The bulk of this guidance focuses on trial design issues and clinical assessments. The document concludes with an examination of product safety determinations.
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.