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Mintz - Health Care Viewpoints

FDA in Flux — July 2025 Newsletter

Mintz - Health Care Viewpoints on

Welcome to FDA in Flux — A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies....more

Benesch

Dialysis & Nephrology Digest - February 2025

Benesch on

A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

Knobbe Martens

FDA Provides Perspective on Goals and Challenges for Regulation of Artificial Intelligence in Medical Devices, Drug Design, and...

Knobbe Martens on

A recent article authored by Haider J. Warraich, MD; Troy Tazbaz; and Robert M. Califf, MD in the Journal of the American Medical Association, reviews the history of artificial intelligence (AI) regulation by the U.S. Food...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

McDermott Will & Schulte on

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

King & Spalding

Not Quite the Titanic: The Food and Drug Omnibus Reform Act Rescues Some FDA Policy Initiatives

King & Spalding on

The Food and Drug Administration (“FDA” or the “Agency”) user fee negotiations may have hit an iceberg, but it did not sink all the legislative riders that accompanied this summer’s House and Senate bills. Buried within the...more

Gardner Law

Transatlantic Legal-Regulatory Update: Live from the Heart of Silicon Valley

Gardner Law on

US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more

Goodwin

Things for Pharma and Biotech Companies to Watch in the Cures 2.0 Proposed Legislation

Goodwin on

Last week, Diana DeGette (D-CO) and Fred Upton (R-MI) introduced in the House highly anticipated bill language for “Cures 2.0”, a follow-up to the transformational 21st Century Cures Act enacted in 2016... The 21st Century...more

Hogan Lovells

The global impact of COVID-19 on clinical trials and countermeasure development

Hogan Lovells on

The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more

Arnall Golden Gregory LLP

FDA Detects That a Screening Tool for Early Detection of Cancer Types Might Require More Sleuthing

Arnall Golden Gregory LLP on

The Food and Drug Administration recently issued an untitled letter to a medical device company concerning its non-invasive blood test intended for use as a screening tool for the early detection of certain cancer types. FDA...more

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