FDA Regulation of OTC Drugs in the U.S. & New Legislation

Pre Recorded

  • 60 minutes

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.

This presentation and learn how coming legislative changes will impact their current OTC products and future products that they may want to market. Regulatory tips and insights will be offered. Fifteen minutes will be allotted for questions and answers.

Join this session by expert speaker Norma Skolnik, where she will illustrate why it’s essential to understand FDA regulations and OTC labeling requirements to market OTC drugs in the U.S.

Session Highlights:

  • Basic FDA regulations for marketing OTC Drugs in the U.S.

  • OTC Drug Labeling requirements

  • OTC Drug registration requirements

  • FDA Adverse Event Reporting requirements for OTC Drugs

  • New Legislation: OTC Drug Monograph Safety, Innovation & Reform Act

Why You Should Attend:

The learning benefits for the attendee include gaining an understanding of current FDA requirements and new legislation that will impact changing FDA regulations for OTC drugs. The webinar will convey insights into how the OTC Drug Safety, Innovation & Reform Act will affect their OTC drug products.

Who Should Attend:

  • Regulatory Affairs Managers and Regulatory Affairs associates

  • OTC Drug and Consumer Healthcare product managers

  • Anyone interested in marketing FDA OTC regulated products 

*You may ask your Question directly to our expert during the Q&A session.

** You can buy On-Demand and view it as per your convenience.

Norma Skolnik

Norma Skolnik

Norma Skolnik is currently a Regulatory Consultant with over 35 years of regulatory experience working with the pharmaceutical and dietary supplement industries. She was Director of Regulatory Affairs for the Americas for Cadbury Adams and Director of Regulatory Affairs for the Adams division of Pfizer before that. Prior to that she was Associate Director of Regulatory Affairs for the Warner-Lambert company and Associate Director Regulatory Affairs at American Home Products Whitehall-Robbins Division.

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