FDA Regulations for Marketing OTC Drugs in the U.S.

Why Should You Attend:

Understanding U.S. FDA regulations and the OTC monograph system and its labeling requirements will help companies assure compliance and enable those who want to market U.S. drug products to make optimal OTC label and promotional claims. It will also help those who attend avoid FDA issues, U.S. importation problems, and FDA warning letters. Helpful regulatory tools and references (including website references) as well as know-how tips will be provided.

Areas Covered in the Webinar:

• Basic U.S. OTC drug labeling requirements
• OTC drug monographs and their importance in drug labeling compliance
• FDA drug facts labeling regulations
• How to use the OTC monographs to achieve the best product labeling
• FDA serious adverse event reporting label requirements

Who Will Benefit:

• Regulatory affairs managers, directors and associates
• Compliance specialists
• Marketing managers
• Anyone planning to market, label or promote OTC drug products in the U.S.

Instructor Profile:

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 as associate director of marketed product support for Lederle Laboratories and associate director of regulatory affairs for Wyeth.

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