Hardware Podcasts

047 - "Truthful Not Misleading" with Darshan Kulkarni

Let's Combinate · 24 Aug 2022 · 1h 00m

What this episode covers

Darshan Kulkarni, an FDA regulatory attorney and Adjunct Law Professor at Drexel University, explains the distinction between regulatory and legal compliance in the life sciences industry. He details how the First Amendment influences US promotional compliance, particularly regarding off-label speech and the 'truthful not misleading' standard established by recent court cases. Kulkarni also discusses the operational differences between FDA divisions for drugs (OPDP) and devices (CDRH), noting the latter's limited enforcement resources, and highlights the implications of the Sunshine Act on physician interactions.

Most relevant to

established companies

Topics

Mentioned

Companies
Kulkarni Law Firm
Products
Saras
Also
Drexel University, Thomas Jefferson University, FDA, OIG, DOJ, Sunshine Act, OPDP, CDRH

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