FDA Regulations for Marketing OTC Drugs and New Legislation

This training program will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market 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.