This training on over-the-counter drug products will help the attendees understand how OTC drug products are regulated by FDA and will explain the regulatory pathways (monograph and NDA), labeling and marketing requirements, and potential enforcement risks.

Why Should You Attend:

Over-the-counter (OTC) drug products are sold directly to consumers without the need of a prescription from a healthcare provider. In the US, these products are regulated by the Food and Drug Administration (FDA). Because of the large number of marketed OTC drug products, the FDA reviews the active ingredients and labeling of over 80 therapeutic classes of drugs (e.g., analgesics) instead of individual drug products.

This webinar will provide clarification on determining a regulatory pathway to bring your OTC drug product to market. Upon completion of this session, participants will have a better understanding of how OTC drug products are regulated by the FDA and will know the regulatory pathways (monograph and NDA), labeling and marketing requirements, and potential enforcement risks.

Areas Covered in the Webinar:

• Overview of FDA OTC drug product regulation
• Utilizing the OTC monograph system as a regulatory pathway
• Following the NDA route as a regulatory pathway
  • Direct to OTC
  • Rx-to-OTC Switch
  • Monograph Deviation
  • Generic
• OTC labeling and marketing considerations
• Potential FDA enforcement risks

Who will Benefit:

This webinar will provide valuable assistance to:

• Regulatory Affairs professionals
• Project Managers
• QA & QC Managers
• OTC drug manufacturers
• Consultants
• Any individuals interested in the OTC drug industry

Instructor Profile:

Camille Davis Thornton, M.S., RAC is the founder of MACE Concepts, LLC, an independent consultancy specializing in providing innovative regulatory, compliance, and training solutions. Ms. Thornton has an M.S. in Biotechnology from The Johns Hopkins University and certifications from the Regulatory Affairs Professionals Society (RAC-US) and the National Restaurant Association (ServSafe® Food Protection Manager, Instructor, and registered Examination Proctor). Additionally, she has over 15 years of experience in multiple regulated industries and actively teaches at the college level. Ms. Thornton areas of expertise include regulatory filings, the FDA Electronic Submissions Gateway (ESG), and liaising with government agencies. Also known as the “Perpetual Inquisitive Geek”, she regularly reviews applicable guidance documents, notifications, newsletters, blog postings, and email alerts from various government agencies to stay up-to-date with current requirements and industry trends. She is a regulatory affairs professional and trainer with a true passion for sharing knowledge effectively.