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Twin Cities Webcast: Advertising and Promoting On- and Off-Label Information Under the FDCA

RAC Credits
Thursday, 05 November 2020 (12:00 PM) - Thursday, 05 November 2020 (1:00 PM) Central Time (US & Canada)

Member: FREE
Nonmember: $20

Your participation in the regulatory community is vital. Currently, RAPS Chapter in-person events are converted to webcasts so that regulatory professionals have online access to valuable knowledge necessary to understand the daily impact on our industry. RAPS is offering this webcast for free to members and $20 for non-members.


This webcast will cover the contours of the law, regulations, guidance, and court cases shaping how the U.S. Food and Drug Administration (FDA) views the current state of the law on promoting devices and drugs under the Food, Drug & Cosmetic Act. There will be a special focus on promoting 510(k) devices under FDA's General/Specific Use and 510(k) guidance documents, mostly related to determining what is on and off-label.   

There will be a discussion on the impact of the court cases that allow for the exchange of medical and scientific information of off-label uses and the right to lawfully promote certain off-label uses under the First Amendment's protection outlined in the Howard Root/Vascular Solutions case and others. We will also examine the content and impact of FDA's recently proposed rule on "Regulations Regarding Intended Uses," modifying 21 CFR Parts 201 and 801, recently published on September 23, 2020. 

Come and explore what may be possible on your promotional horizon and the potential enforcement risks. This session is not only for regulatory affairs professionals, but it will also be useful information for executives and those in marketing and sales and compliance.

The webcast will conclude with a Q&A segment.

This event is brought to you by the RAPS Twin Cities Chapter to encourage knowledge sharing and community development. RAC holders may claim 1.0 RAC recertification credit.

Learning Level: Intermediate to Advanced

Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity. 

Advanced: Content is designed for individuals who are well-versed in most, if not all, concepts associated with the topic(s). Activities place a high concentration on analysis and application of concepts or demonstration of competencies through exercises such as case studies, scenario building, and group projects. A high level of participation is expected from each attendee.

This webcast is available to RAPS members for free. RAPS membership provides vital information for regulatory professionals, as well as a place for networking and invaluable connections. 

Now is a great time to explore the many benefits to RAPS membership, including the Member Knowledge Center and our award-winning, private online community, Regulatory Exchange. 

Find out more about RAPS membership today.

How Do Webcasts Work?

For the best webcast experience, please use the Google Chrome browser. RAPS webcasts are also mobile- and tablet-accessible for your convenience. Registrants will receive instructions on how to log in 24 hours before the start of the webcast. A live Q&A portion with the speaker will follow the presentation. 

Featured Speakers:
Mark DuVal, president, DuVal & Associates
Aaron Hage, associate attorney, DuVal & Associates