Norma Skolnik
Instructor Norma Skolnik
Product Id 601099
Duration 60 Minutes  
Version Recorded
Original Price $300
Special Offer Price $15
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Meeting FDA requirements for OTC Drug Labeling

Overview:

The webinar will help participants review and understand FDA requirements for OTC Drug labeling and compliance. OTC Monographs and their importance to OTC Drug marketing in the U.S. will also be covered.

Why Should You Attend: Anyone who wants to market OTC drugs in the U.S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/webinar. It will provide background for OTC Drug labeling regulations and an understanding of how to comply with FDA requirements. Potential FDA enforcement actions regarding OTC drug labeling will also be covered.

Areas Covered in the Session:

  • OTC Drug Labeling regulations: background and requirements
  • Drug Facts labeling
  • OTC Monographs and their importance
  • Conditions under which OTC Drugs can be marketed in the U.S.A.

Who Will Benefit: Anyone who wants to market OTC drugs in the U.S.A. and assure that they're labeled properly with appropriate claims will benefit from this program/webinar:
  • Regulatory Professionals
  • Drug Marketers
  • Manufacturers and Distributors
  • Students of FDA Regulations

Speaker Profile
Norma Skolnik has 30 years of regulatory experience in the OTC Drug, Food and Dietary Supplement industries. She has had extensive experience advising on regulatory strategies for new and marketed consumer healthcare products. Particularly regarding the development and review of optimal product claims and advertising. For 10 years, Norma served as Director of Regulatory Affairs for Cadbury Adams, Americas (formerly Adams Division of Pfizer). Previously she was Associate Director of Regulatory Affairs at Wyeth Consumer Healthcare and Associate Director, Regulatory Affairs at Lederle Consumer Health division of American Cyanamid.

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