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Articles by Bonnie Odom
Sharing Scientific Information with HCPs on Unapproved Uses of Medical Products: Dos and Don’ts Under FDA’s New Draft Guidance | JD Supra
In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers Guidance for Industry” (“2023 Draft Guidance”).[1] The 2023 Draft Guidance supersedes previous draft guidance from 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“2014 Draft Guidance”), which was a revision of a...
Cultivating Sustainability: European Commission Greenlights Italy’s EUR 1.7 Billion Agrivoltaic Initiative
On Nov. 10, 2023, the European Commission authorized a State aid scheme presented by Italy, earmarking EUR 1.7 billion to bolster agrivoltaic plants. The initiative aligns with Italy’s overarching strategy to curtail greenhouse gas emissions and increase the utilization of renewable energies, consistent with the European Union’s strategic goals outlined in the European Green Deal. The funds, in part, originate from the Recovery and Resilience Facility (RRF).
Congress Clarifies the Regulatory Classification of Contrast Agents, Radioactive Drugs, and OTC Monograph Drugs | JD Supra
On December 29, 2022, President Biden signed into law H.R. 2617, the Consolidated Appropriations Act of 2023 (CAA23). Buried in this massive piece of legislation is Section 3621, Regulation of Certain Products as Drugs, which deems all “contrast agent[s], radioactive drug[s], [and over-the-counter (OTC)] monograph drug[s]” to be drugs, as opposed to medical devices.
Podcast: President Biden’s Use of the Defense Production Act – Diagnosing Health Care
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Building Compliance Programs for AI Tools | JD Supra
Artificial Intelligence (“AI”) applications are powerful tools that already have been deployed by companies to improve business performance across the health care, manufacturing, retail, and banking industries, among many others. From largescale AI initiatives to smaller AI vendors, AI tools quickly are becoming a mainstream fixture in many industries and will likely infiltrate many more in the near future.
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