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An Introduction to FDA’s Regulation of Over-the-Counter (OTC) Drug Products

Date: 18-Jul-12 to 18-Jul-12
Location: Online Event / California / United States
Category: Healthcare & Pharmaceuticals Conferences & Trade Fairs

This webinar will provide an introduction to the FDA’s regulation of Over-the-Counter (OTC) drug products and the various methods for bringing such a product to market. You will learn the various options for marketing an OTC drug, gain an understanding of FDA’s relevant labeling and promotional rules, and learn strategies for mitigating the potential risk for FDA regulatory enforcement.

Visitors

Why Should You Attend:

All OTC drugs are regulated by the U.S. Food and Drug Administration’s (“FDA”) and can enter the market in one of the following ways: (a) by complying with an applicable monograph; (b) as the subject of an FDA approved New Drug Application; or (c) via an FDA approved Rx-to-OTC Switch.

Most of the OTC drugs available today are marketed and sold as OTC monograph drug products. Although still a very, very small percentage of the total number of OTC drug products on the market, the Rx-to-OTC Switch regulatory pathway is becoming increasingly popular for placing OTC drugs on the shelves as companies look for ways to extend the life cycle of their branded prescription products.

Exhibitors

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. He provides regulatory advice and counseling to domestic and international pharmaceutical, OTC and consumer product companies on issues related to the U.S. Food and Drug Administration’s regulation of the manufacture, labeling, distribution, marketing and sale of drugs, dietary supplements, devices and food. He regularly works with companies on labeling and marketing compliance; provides counseling to clients during FDA enforcement proceedings; and supports due diligence efforts related to product line and company acquisitions in the pharmaceutical, OTC drug and dietary supplement sectors.

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