FDA Regulation of Hand Sanitizers; What Testing Should be Conducted to Market a New Hand Sanitizer?
Автор: Nelson Labs
Загружено: 2022-05-12
Просмотров: 230
Описание:
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 will discuss the required in vitro and clinical safety & efficacy testing to conduct and important study design considerations.
Key Learning Objectives:
• FDA monograph and current requirements
• What is required for Safety Testing
• What are the Applicable screening tests and basic methodologies
• Overview of clinical evaluations for hand sanitizers
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