News & Insights

News & Insights

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Jeffrey K. Shapiro

News 11 results

In the News · Source: Law360

March 20, 2025
Paul Mezzina, Jeffrey Shapiro, Madison Kitchens and Caroline Freeman counsel MiMedx in a dispute with the FDA before a Georgia federal court

Recognition

June 12, 2024
King & Spalding Earns Top-Tier Rankings in Legal 500 United States 2024 Guide

In the News · Source: InsideHealthPolicy

February 2, 2024
Jeff Shapiro examines whether the FDA’s decision to let a large swath of diagnostic tests seek market clearance through the 510(k) process will ease tensions over the agency’s proposal to reassert jurisdiction over laboratory-developed tests

In the News · Source: Inside Health Policy

January 29, 2024
Jeff Shapiro discusses whether the FDA will have the necessary resources to take on the job of regulating laboratory developed tests if it finalizes its rule to reassert jurisdiction over the diagnostics

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Events 6 results

Speaking Engagement

February 26, 2025
Jeffrey Shapiro to Speak at 2025 RAPS (Regulatory Affairs Professionals Society)

Conference

September 5, 2024
17th Annual King & Spalding Medical Device Summit

Speaking Engagement

March 12, 2024
Jeffrey Shapiro and David Farber to Speak at Fogarty Innovation

Speaking Engagement

February 14, 2024
Jeffrey Shapiro to Speak at RAPS Workshop: Digital Health: Fundamentals of FDA Regulation Live Virtual Event

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Insights 20 results

Client Alert

May 9, 2025
New Executive Order Promotes Domestic Production of Critical Medicines

Article · Source: Journal of Health Care Compliance

May 1, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

Client Alert

April 4, 2025
FDA's LDT Rule Struck Down by Court: FDA Has Lost the Battle, But Is the War Over?

Client Alert

January 10, 2025
FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

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