News & Analysis as of

Medical Devices Regulatory Requirements Trump Administration

Akin Gump Strauss Hauer & Feld LLP

Regulatory Relief for Certain Stationary Sources to Promote American Security with Respect to Sterile Medical Equipment (Trump EO...

This proclamation addresses the EPA’s April 5, 2024 final rule, National Emission Standards for Hazardous Air Pollutants: Ethylene Oxide Emissions Standards for Sterilization Facilities Residual Risk and Technology Review, 89...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Alston & Bird

Health Care Week in Review | Trump Administration Releases FY 2026 Budget Proposal; CMS Launches Oversight Initiative on Medicaid...

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Hogan Lovells

AI Summit panelists forecast FDA regulatory climate in second Trump administration

Hogan Lovells on

Evolving regulatory paradigms governing AI use in health care at the U.S. Food and Drug Administration (FDA) have set the pace for AI regulatory frameworks worldwide. Jodi Scott, partner in the Hogan Lovells medical device &...more

Skadden, Arps, Slate, Meagher & Flom LLP

Mass Layoffs at FDA Could Have the Greatest Impact on Products in Development - The Trump Administration’s First 100 Days

Companies that interact with FDA are likely to find that the layoff of 3,500 employees on April 1, 2025, affects their dealings in a variety of ways....more

Mintz - Health Care Viewpoints

A Texas Federal Court Sides with Laboratories, But There May Be Unintended Consequences for FDA

The obvious result of the legal shootout between the U.S. Food & Drug Administration (FDA) and clinical laboratory trade associations, the American Clinical Laboratory Association and the Association for Molecular Pathology,...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA at the Start of the Trump Administration: A Cheat Sheet

There has been a flurry of activity at the Food and Drug Administration (FDA) since the start of the Trump administration. Day-to-day operations at FDA are already significantly altered, and we expect the trickle-down effects...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Second Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Morgan Lewis

How New Executive Orders May Affect FDA’s Medical Device Operations

Morgan Lewis on

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device and digital health...more

Skadden, Arps, Slate, Meagher & Flom LLP

Gauging the Likelihood of Trump Administration FDA Reforms

Since the announcement that president-elect Donald Trump would nominate Robert F. Kennedy Jr. (RFK Jr.) as the secretary of the U.S. Department of Health and Human Services (HHS), media reports have featured opinions from...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 10, December 2024

Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more

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