This webinar will provide attendees with the knowledge and skills needed to develop and produce an OTC drug product for marketing and sale in the U.S.
FDA and CPSC requirements for OTC drugs will be covered. There will also be some discussion of the market differences between Rx and OTC products.
Why Should You Attend:
This webinar will discuss U.S. FDA and Consumer Product Safety Commission regulation of OTC drug products and strategic recommendations for mitigating the risk of enforcement action in the future. Attendees will gain an understanding of various available options for producing and selling an OTC drug product.FDA and CPSC requirements for OTC drugs will be covered. There will also be some discussion of the market differences between Rx and OTC products.
Learning Objectives:
- Gain a comprehensive understanding of how OTC drug products are regulated in the U.S.
- Learn to distinguish between a potential Rx pharmaceutical product and an OTC drug.
- Recognize the difference between the various pathways for commercializing an OTC drug product.
- Understand how to identify and successfully navigate an OTC Drug Monograph.
- Recognize when reliance on a Proposed Rule, Final Rule and/or Drug Monograph is appropriate.
- Understand how to determine whether an Ingredient is considered Safe or GRAS/E for use in an OTC drug and understand the difference between Category I, II and II Ingredient designations.
- Identify the required elements of a compliant OTC Drug Label.
- Take away strategies for marketing and promoting OTC drug products, and for mitigating potential enforcement risks.
- Possess a working knowledge of the Rx-to-OTC Switch Process.
- Review and evaluate several of FDA’s current OTC Monographs
Areas Covered in the Webinar:
- Claims for drugs, devices, medical foods and cosmetics
- NDA, ANDA and OTC Monographs for OTC Drugs
- Rx to OTC Switches
- cGMPs for OTC drugs
- Tamper Evidence and Poison Control
- Branded Innovator, Branded Generic and Generics
Who Will Benefit:
- Regulatory affairs managers, directors and associates
- Compliance specialists
- Marketing managers
- Quality professionals
- Document control specialists
- Record retention specialists
Speaker
Loren GelberCourse Provider
Loren Gelber,
