Best Practices for Evaluating an Rx to OTC Switch: Critical Legal and Regulatory Considerations

Zuckerman Spaeder LLP partner Andrew N. Goldfarb spoke at ACI’s Legal, Regulatory and Compliance Forum on Over the Counter Drugs in New York City as part of an October 18, 2012 morning panel presentation entitled “Best Practices for Evaluating an Rx to OTC Switch: Critical Legal and Regulatory Considerations.”

The panel addressed a variety of topics including identifying prescription products appropriate as candidates for over-the-counter (OTC) status, the FDA push for the creation of a third category of drug products, and key consideration in risk-benefit analysis for a switch from prescription to OTC status.

Event Speakers

  • Andrew N. Goldfarb
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Katie Munroe
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