FDA Regulation for Over-the-Counter (OTC) Drug Products

Description

This 90-minute webinar provides a comprehensive overview of the FDA's regulation of Over-the-Counter (OTC) drugs, covering key aspects such as regulatory frameworks, approval processes, labeling requirements, and compliance considerations. Participants will gain a clear understanding of the regulatory requirements governing OTC drugs, including the OTC Monograph System, labeling guidelines, and compliance with current Good Manufacturing Practices (cGMP).

 The webinar will explore the differences between OTC Monograph submissions and New Drug Applications (NDA), as well as the timeline and requirements for OTC drug approval. Additionally, participants will learn about important considerations for OTC drug development, including nonclinical and clinical studies, establishing product safety and efficacy profiles, and ensuring clear and accurate communication with consumers through labeling and marketing. Compliance and enforcement aspects, including FDA inspections and common compliance issues, will also be discussed. By attending this webinar, participants will gain practical insights and strategies to navigate the regulatory landscape effectively…