4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

Instructor: Norma Skolnik
Product ID: 704530
  • Duration: 4 hrs
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The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.

Why Should You Attend:

OTC drugs and consumer healthcare products have a significant place in the U.S. healthcare market. OTC drug products are taking on an increasingly important role as consumers look for cost savings in self healthcare. Compliance with FDA regulations for OTC drugs is essential in marketing OTC drugs successfully and avoiding regulatory issues.

The cost of non-compliance with FDA regulations can mean inability to import your products into the U.S. and receipt of FDA Warning Letters that could require you to relabel your products or prevent you from marketing your OTC drug products.

This virtual seminar will provide attendees with an essential overview of the laws and regulations covering OTC products in the U.S. and requirements for marketing and labeling these products. It will also help in thoroughly understanding the complexities of and challenges associated with this class of drug products. Additionally, review of FDA Warning Letters to OTC drug companies will help you learn how to avoid serious regulatory problems.

Learning Objectives:

  • Understand FDA regulations for marketing OTC drugs in the U.S.
  • Understand FDA requirements for registration of drug facilities and drug listing requirements
  • Be able to implement compliant FDA OTC drug labeling requirements
  • Understand the importance of OTC drug monographs and how they can help market your product and make the best claims
  • Be able to develop successful implementation plans for registering, manufacturing, labeling and marketing OTC drug products in compliance with FDA regulations
  • Understand basic drug Current Good Manufacturing Practice requirements

Areas Covered in the Webinar:

  • Background and history of FDA OTC drug regulations
  • How OTC drugs can be marketed in the U.S. in compliance with FDA regulations
  • Overview of U.S. OTC drug labeling requirements
  • OTC drug monographs and their importance to product marketing
  • Summary of OTC GMP regulations
  • FDA rules for adverse event reporting of OTC Drugs
  • Why OTC drugs get FDA Warning Letters and how to avoid them

Who Will Benefit:

  • Regulatory affairs managers
  • Directors and associates
  • Compliance specialists
  • Marketing managers
  • Anyone planning to market or import OTC drugs into the U.S.

Instructor Profile:

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. She currently works as a regulatory consultant.

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