A follow-up to our October 7 webinar on FDA’s new final rule on intended use, this virtual roundtable will share practical guidance for legal, compliance, and regulatory affairs professionals responsible for mitigating risks associated with external communications and other activities implicated by the final rule. Our panelists will explore:
- How the final rule has changed day-to-day counseling on non-promotional activities, including responses to unsolicited requests, dissemination of reprints and clinical practice guidelines, industry-supported scientific and educational activities, and payor communications
- The First and Fifth Amendment implications of the amended regulations
- Circumstances in which constitutional arguments may be deployed in opposition to FDA’s expansive interpretation of intended use
SPEAKERS
Coleen Klasmeier (Moderator), Partner & Global Leader, Food, Drug and Medical Device Regulatory Practice
Torrey Cope, Partner, Food, Drug and Medical Device Regulatory Practice
Joseph Guerra, Partner, Supreme Court and Appellate Practice
Jaime Jones, Partner & Global Co-Leader, Healthcare Practice
For more information, contact GlobalLifeSci@sidley.com.