Market and Sell an Over-the-Counter Drug Product in the United States April 19, 2013

This training on OTC drug marketing is intended to be a practice-based online workshop that will explain what you need to know to successfully market and sell an Over-the-Counter drug product in the United States; and provide strategic advice for avoiding FDA enforcement action.

Why Should Attend:

This online workshop will provide attendees with a comprehensive review and understanding of the process for designing, developing, manufacturing and selling an OTC Drug Product in the U.S. For purposes of regulatory compliance, the workshop will also focus on FDA’s regulatory requirement covering OTC drug products; and offer strategic recommendations for not only success but also for mitigating the risk of FDA enforcement risk and general liability.

Some of the topics to be covered during this online workshop will include:

- FDA’s requirements for marketing and selling an OTC drug product in the U.S.
- Methods for determining whether a drug product can be marketed and sold as an OTC drug
- The regulatory pathways for commercialization of an OTC drug product
- The OTC Monograph process and Understanding how to Use Them
- FDA’s permitted Rx-to-OTC Switch Process
- How to properly label and market an OTC drug product, and
Strategies for mitigating regulatory enforcement risks and liability.