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On-Label, Extra-Label, and Off-Label: Strategizing Medical Device Communications under FDA Regulations and Guidance (The Musical Edition)

  • 1.  On-Label, Extra-Label, and Off-Label: Strategizing Medical Device Communications under FDA Regulations and Guidance (The Musical Edition)

    Posted 21 days ago
    Join the 𝐓𝐰𝐢𝐧 𝐂𝐢𝐭𝐢𝐞𝐬 𝐑𝐀𝐏 𝐂𝐡𝐚𝐩𝐭𝐞𝐫 for an In-Person Event!

     𝘖𝘯-𝘓𝘢𝘣𝘦𝘭, 𝘌𝘹𝘵𝘳𝘢-𝘓𝘢𝘣𝘦𝘭, 𝘢𝘯𝘥 𝘖𝘧𝘧-𝘓𝘢𝘣𝘦𝘭: 𝘚𝘵𝘳𝘢𝘵𝘦𝘨𝘪𝘻𝘪𝘯𝘨 𝘔𝘦𝘥𝘪𝘤𝘢𝘭 𝘋𝘦𝘷𝘪𝘤𝘦 𝘊𝘰𝘮𝘮𝘶𝘯𝘪𝘤𝘢𝘵𝘪𝘰𝘯𝘴 𝘶𝘯𝘥𝘦𝘳 𝘍𝘋𝘈 𝘙𝘦𝘨𝘶𝘭𝘢𝘵𝘪𝘰𝘯𝘴 𝘢𝘯𝘥 𝘎𝘶𝘪𝘥𝘢𝘯𝘤𝘦 (𝘛𝘩𝘦 𝘔𝘶𝘴𝘪𝘤𝘢𝘭 𝘌𝘥𝘪𝘵𝘪𝘰𝘯) 🎶

    📅 Date: May 14, 2026
    ⌚ Time: 5:30 – 7:30 pm
    📍 Location: SCSU at Plymouth, 9750 Rockford Rd, #100 Plymouth, MN 55442
    👤 Speaker: Bryan Feldhaus, JD, LL.M: President, DuVal & Associates, P.A., LinkedIn profile: https://lnkd.in/gSxj2ukK
    Link 

    This session is designed to position Regulatory to become a strategic business partner when developing and reviewing advertising, promotional and labeling materials, with a focus on discernment between on-label, extra-label, and off-label claims.
    Registration Link: Twin Cities Chapter In Person Event: On-Label, Extra-Label, and Off-Label: Strategizing Medical Device Communications under FDA Regulations and Guidance (The Musical Edition) | RAPS 
    Sponsored by DuVal & Associates, P.A. (Will provide dinner for event).


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    Georgiann Keyport MSc, RAC, FRAPS
    Founder, Senior Advisor, Regulatory, Quality and Clinical Affairs Consultant, Adjunct Faculty
    Canopy Regulatory Solutions Inc.
    Chaska MN
    United States
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