FDA gingivitis guidance
This article was originally published in The Tan Sheet
Executive Summary
OTC gingivitis products should carry the labeling claim "helps prevent gingivitis" while Rx drugs may include the more scientific phrase "reduction of disease incidence," FDA recommends in a FDL-1draft guidance published in the Federal Register June 28. "Gingivitis: Development & Evaluation of Drugs for Treatment or Prevention" focuses on trial design issues and clinical assessments involved with developing both Rx and OTC products for the condition. Recommended inclusion criteria for clinical trials such as "a specified number of teeth present" and "a qualifying baseline plaque index" are provided by the agency, while exclusion criteria include "chronic disease with concomitant oral manifestations." A definition of the difference between prevention and treatment of the condition also is included...
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