An Introduction to FDAâ€™s Regulation of Over-the-Counter (OTC) Drug Products (Pharmaceuticals)
Venue: Online Event
|Event Date/Time: Jul 18, 2012||End Date/Time: Jul 18, 2012|
Why Should You Attend:
All OTC drugs are regulated by the U.S. Food and Drug Administrationâ€™s (â€œFDAâ€) 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.