FDA Regulations for Marketing & Labeling OTC Drugs In The U.S.
Duration : 60 Minutes
Norma Skolnik,
Norma Skolnik has over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She served as Director of Regulatory Affairs for the Americas for Cadbury Adams. Prior to that she was Director of Regulatory Affairs for the Adams Division of Pfizer and Associate Director of Regulatory Af Read more
OTC Drugs and Consumer Healthcare products have a significant place in the U.S. healthcare market. OTC drug products are taking on an increasingly important role as consumers look for cost savings in
The cost of non-compliance with FDA regulations can mean
This virtual seminar will provide you with an essential overview of the laws and regulations covering OTC products in the U.S. and requirements for marketing and labeling these products. It will also help you thoroughly understand the complexities of and challenges associated with this class of drug products. Additionally, review of FDA Warning letters to OTC drug companies will help you learn how to avoid serious regulatory problems.
Course Objectives:
• Understand FDA regulations for marketing OTC drugs in the U.S.
• Be able to implement compliant FDA OTC drug labeling requirements.
• Understand Drug Current Good Manufacturing Practices.
• Understand the importance of OTC Drug Monographs and how they can help make the best claims.
• Be able to develop successful implementation plans for registering, manufacturing, labeling
Course Outline:
• Background & History of FDA OTC Drug Regulations
• How OTC Drugs can be Marketed in the U.S. in compliance with FDA Regulations
• Overview of U.S. OTC Drug Labeling requirements
• OTC Drug Monographs and their Importance to product Marketing
• Summary of OTC GMP regulations
• FDA Rules for Adverse Event Reporting of OTC Drugs
• Why OTC Drugs get FDA Warning Letters and How to Avoid Them
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
• Regulatory Affairs managers,
• Directors & Associates,
• Compliance Specialists,
• Marketing Managers, and anyone planning to market or import OTC Drugs into the U.S.
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
