To market Over-the-counter (OTC) drugs in the U.S., it is essential to understand the regulations and labeling requirements of the Food and Drug Administration (FDA). Understanding FDA’s regulations and the labeling requirements of the OTC monograph system will not only help assure compliance, but will also enable those who want to market U.S. products to make optimal label claims and avoid FDA issues and Warning letters.
Join this session by expert speaker, Norma Skolnik, to understand the concepts regarding U.S. OTC Drug labeling requirements. She will also discuss OTC Drug Monographs and their importance to Drug Labeling compliance.
Who Should Attend
Regulatory Affairs managers and associates, QA mangers, OTC Drug Marketing managers, and anyone interested in learning about U. S. OTC Drug labeling requirements
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
- Charles H. Paul,
- Robert J. Russell,
- Greg Sperla and Anthony J. Cortez,
- Jeff Kasoff, RAC, CMQ/OE, LBB
- Danielle DeLucy, MS
- 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 Affairs for the Warner-Lambert company. She also served as Director of Regulatory Affairs for Lederle Consumer Healthcare and...
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