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

    /Norma  /Skolnikspeaker of compliance global
    Speaker: Norma Skolnik
    Duration: 60 Minutes
    Product Code: 700172
    Level: Intermediate
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The webinar will offer an overview of FDA requirements for marketing, labelling and promotion of OTC drugs in the U.S. It will cover how OTC pharmacy can be effectively marketed and the OTC Monographs and their importance to compliance in general and drug labels in particular. Challenges of marketing OTC drugs in the U.S. will be covered.

why should you attend

Attendance is important to assure that your OTC drug products are in compliance with FDA food regulations and to learn about how the OTC monographs can help you market your drug products effectively. Helpful references to websites and relevant regulations and know-how tips will also be provided.

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Areas Covered

•   Background and History of OTC Drug regulations
•   Different Ways that OTC Drugs can be Marketed in the U.S. (NDA, Rx to OTC Switch vs. Monograph process)
•   Overview of the OTC Drug Monographs and Their Importance
•   FDA Drug Facts Labelling Requirements
•   FDA Regulations for Required Adverse Event Reporting

Learning Objectives

•   To become familiar with FDA regulations for marketing OTC drugs in the U.S.
•   In-turn assure compliance and more effectively market OTC products


•   Regulatory Affairs Managers and Associates
•   QA Managers
•   OTC Drug Marketing Managers
•   Anyone interested in learning about U. S. OTC Drug regulatory requirements and compliance


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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