Hardware Podcasts

Ad Promo and The Difference in Regulatory & Legal

Global Medical Device Podcast · 24 May 2023 · 1h 26m · Episode 320

What this episode covers

Mark DuVal, founder of Duval & Associates, explains the '4 buckets' framework for medical device promotion: on-label promotion, off-label dissemination, off-label communication, and the emerging fourth bucket of off-label promotion with disclosures. He contrasts the scientific perspective of regulatory affairs professionals with the advocacy-driven approach of regulatory attorneys, emphasizing the legal tension between FDA enforcement and First Amendment rights established in cases like *Howard Root* and *Washington Legal Foundation*. DuVal details how companies can navigate these boundaries using guidance documents, ensuring all communications are 'truthful, not misleading, and fairly balanced,' while managing risks like strict liability for executives and compliance monitoring of contract sales forces.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru, Duval & Associates, 3M, Coaxia
Also
FDA, Washington Legal Foundation, Howard Root

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