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

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.

Areas Covered in the Seminar:

• FDA's regulation of over-the-counter drug products or OTC drugs.
• Bringing an OTC drug to market under an OTC monograph.
• Where to find FDA's list of existing monographs and identification of the various product categories covered by monographs.
• An introduction to FDA's Rx-to-OTC Switch procedures and the benefits / challenges of pursuing such an option.
• Labeling an OTC drug product.
• Potential FDA enforcement risks.