This course will cover all aspects of FDA regulation of Over the Counter (OTC) pharmaceuticals. The FDA requirements for marketing a product OTC will be explained. Compliance with OTC monographs, products that start out as prescription drugs and then are switched to OTC, and products that start out as OTC drugs will be discussed. How to market each type will also be covered. FDA requirements for the ingredients in and labeling of OTC products will be considered. How frequently to expect FDA inspections, how to handle FDA inspections and how to avoid FDA Enforcement Actions will also be covered.
Learning Objectives:
After completing this seminar, you will gain a better understanding of how to:
- Develop an OTC Drug
- Comply with an OTC Monograph
- Propose an addition to an OTC Monograph
- Obtain approval for Rx to OTC switch products
- Obtain approval for de novo OTC products
- Avoid FDA enforcement actions
Areas Covered:
- The areas that will be discussed in the seminar will include the following topics throughout the agenda:
- OTC Drug Review Process
- OTC Drug Monographs
- Status of specific OTC Monographs, their included Regulatory Requirements and Strategies for Commercialization
- Rx to OTC Switches
- Direct to OTC NDAs
- OTC Drug Ingredients
- Marketing a drug product that deviates from a final monograph
- OTC Drug Labels, Labeling, Marketing and Advertising Issues
- FDA Enforcement Actions
Who will Benefit:
- Pharmaceutical Research and Development Supervisors
- Management Representatives who select new pharmaceutical products to develop
- Pharmaceutical Regulatory Affairs personnel
- Pharmaceutical labeling and quality personnel
- 08.30 AM - 09.00 AM: Registration and Meet & Greet.
- 09.00 AM: Session Start
- 9:00 -10:30
- Seminar objectives review, expectations and scope.
- Difference between Rx and OTC drugs
- General OTC review process
- OTC Monographs
- 10:30 -10:45 Break
- 10:45 -12:00
- Proposing changes to OTC Monographs
- ANDAs for Rx to OTC switch products
- 12:00 -1:00 Lunch
- 1:00 -2:00
- De novo NDAs for OTC drugs
- Discussion and questions
- 2:00 -2:15 Break
- 2:15 -4:00: more discussions of CGMPs
- OTC ingredients
- OTC Labeling
- 9:00 -10:30
- FDA Enforcement Actions
- FDA Inspections and 483s
- FDA Warning Letters and Import holds
- 10:30 -10:45 Break
- 10:45 -11:30
- Review & Summary.
- Course Evaluations.
- Adjourn.
- 11:30 -12:00 Optional continued discussion of all of the above
Loren Gelber
Regulatory Compliance Consultant (Ex-FDA Official)
Dr. Loren Gelber has more than 40 years in the pharmaceutical industry. She spent her first ten years at FDA, followed by 20 years in Regulatory Affairs and Compliance at various pharmaceutical companies, and the last ten years as a Regulatory Compliance Consultant. During this time she was a member of various groups and committees that worked on many compliance issues. She has published a number of papers and delivered various seminars and talks. Dr. Gelber holds a BA in Biology from Brandeis University, an MS in Chemistry from Brooklyn Polytechnic Institute (now part of NYU) and a PhD in Medicinal Chemistry from Northeastern University School of Pharmacy and Allied Health Professions. She current resides in Charlotte, NC.
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