Potomac Law is pleased to present an upcoming live webinar with Facet Life Sciences entitled “Are You a Drug or Device? Unseen Regulatory and Intellectual Property Impact of Genus.” Occurring on November 23, 2021, Potomac Law partners Jeremy Cubert and Jur Strobos are featured speakers at the event.
Regulatory history was made on 9 August 2021 in a Federal Register notice (Docket No: FDA-2021-N-0843) announcing that in accordance with the Genus decision, FDA intends to regulate products that meet both drug and device definitions as medical devices, except where the statute indicates that Congress intended a different classification.
FDA will now assess the primary intended action and metabolism of imaging agents to determine the right regulatory pathway. Whether a product is regulated as a drug or a device has important implications for patent portfolios and regulatory strategies. And the current situation creates uncertainties for which action taken now may be protective.
Join us for an informative webinar to learn more about the unseen regulatory and intellectual property impact of this landmark decision and how best to reduce risk. Click here to register.
