All hand sanitizers, whether used by consumers or healthcare professionals, are considered over-the-counter (OTC) drugs regulated by the FDA. As with any new human use product entering the market, the FDA mandates compliance with Good Manufacturing Practices (GMP), safety data, and both in vitro and in vivo efficacy data before the product can be marketed to the public.
This presentation will provide a comprehensive overview of the required in vitro and clinical safety and efficacy testing for hand sanitizers. Attendees will gain insights into important study design considerations and the critical steps necessary to meet FDA requirements.
The session will begin by discussing the FDA monograph and current requirements for hand sanitizers. Understanding these regulatory guidelines is crucial for ensuring that products meet the necessary safety and efficacy standards. Participants will learn about the specific criteria set forth by the FDA and how to navigate these regulatory expectations.
Next, the presentation will delve into the requirements for safety testing. This includes a detailed look at the types of safety data that must be collected and the methodologies used to assess the safety of hand sanitizers. Attendees will gain a clear understanding of the essential safety testing protocols that ensure the product is safe for human use.
The session will also cover the applicable screening tests and basic methodologies used in efficacy testing. This involves evaluating the effectiveness of hand sanitizers in eliminating or reducing harmful microorganisms. Participants will learn about the various in vitro and in vivo tests required to demonstrate the efficacy of the product.
Finally, the presentation will provide an overview of clinical evaluations for hand sanitizers. Attendees will gain insights into the design and implementation of clinical studies, including key considerations for conducting robust and reliable clinical evaluations. This section will highlight best practices for ensuring that clinical data supports the safety and efficacy claims of hand sanitizers.
By attending this presentation, professionals involved in the development, testing, and regulatory compliance of hand sanitizers will acquire valuable knowledge on meeting FDA requirements and conducting effective safety and efficacy testing. This knowledge is essential for bringing safe and effective hand sanitizer products to market.