FDA Regulations for Marketing OTC Drugs in the U.S

Event Information
Product Format
Prerecorded Event
Conference Date
Thu, Sep 18, 2014
60 Minutes
Product Description

Marketing, Labeling and Promoting OTC Drugs in the U.S.

It is important to understand how to market, label and promote OTC drugs in the U.S. to be compliant with FDA requirements. In this conference, expert Norma Skolnik will cover the current regulatory trends keeping in mind OTC drug regulations. Norma will focus on the importance of OTC monograms and explain how they can be used to your advantage in marketing and labeling your OTC products. There will be a review of OTC drug labeling requirements as well as discussion of why OTC drugs have come under recent FDA scrutiny and how to avoid regulatory problems and FDA Warning letters. Adverse Event Reporting requirements for OTC drugs will also be reviewed. Discussions on how far you can go with claims for OTC drugs would be done. Specific questions about FDA rules for marketing and labeling of OTC drugs will be addressed and answered. References to all relevant FDA regulations, guidance documents and FDA websites for OTC drugs will be provided as well as regulatory know-how tips.

Training Objective:

  • Background & history of OTC drug regulations
  • Different ways that OTC drugs can be marketed in the U.S.
  • Overview of OTC drug monographs and their importance
  • Drug facts labeling requirements
  • FDA rules for adverse event reporting


Who Should Attend

  • Regulatory affairs managers
  • Directors & associates
  • Compliance specialists and anyone planning to market, label or promote OTC drugs in the U.S

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About Our Speaker

Norma Skolnik - FDA Regulations Expert

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...   More Info
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