All hand sanitizers, whether used by consumers or healthcare professionals, are considered over-the-counter (OTC) drugs that are regulated by the FDA. As with any new human-use product entering the market, the FDA requires Good Manufacturing Practices, safety data, and in vitro and in vivo efficacy data before the product is marketed to the public. This presentation discusses the required in vitro and clinical safety & efficacy testing to conduct and important considerations for study design.

Key areas of discussion:

• FDA monograph and current requirements
• Requirements for safety testing
• Applicable screening tests and basic methodologies
• Overview of clinical evaluations for hand sanitizers

Learn more about the presenter below.