Event:
-
An Introduction to FDA's Regulation of Over-the-Counter
(OTC) Drug Products
- Hosted By:
-
ComplianceOnline
- Start:
- Wednesday - Aug 07, 2013 10:00 AM
- End Time:
- Wednesday - Aug 07, 2013 11:30 AM
- Location:
- Online
- 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.
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.
This webinar will provide beginners with an introduction to FDA’s regulation of OTC drug products. Some of the topics to be covered in this webinar include:
- Whether a drug product can be marketed and sold as an OTC
- The various pathways for bringing an OTC drug to market
- The OTC Monograph process and the products currently covered by monographs
- Switching an Rx drug product to an OTC
- Rules for labeling and marketing an OTC drug product, and
- Strategies for mitigating potential FDA regulatory risks based on recent - Agency enforcement action.
- Website:
-
Visit the website for detail info