FDA Regulation of OTC Drugs in the USA

Event Information
Product Format
Prerecorded Event
Presenter(s)
Conference Date
Fri, Feb 24, 2017
Length
60 minutes
Product Description

Understand the FDA Regulations and Labeling Requirements of OTC Drugs.


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.

Session Highlights

  • U.S. OTC Drug labeling requirements
  • OTC Drug Monographs and their importance to Drug Labeling compliance
  • FDA Drug Facts Labeling regulations
  • How to Use the OTC Monographs to achieve the best product labeling?
  • FDA Adverse Event Reporting requirements for OTC Drugs

Bonus Resources:

  • Citations to all relevant FDA regulations
  • Relevant FDA website references
  • Know-how tips on marketing OTC drugs in compliance with FDA requirements

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.

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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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