News & Analysis as of

Trump Administration Regulatory Reform Medical Devices

Goldberg Segalla

Does EtO’s Recent Regulatory Battle Victory Mean It Will Win the War?

Goldberg Segalla on

Following years of heightened concern about the dangers of exposure to ethylene oxide (EtO), increased regulatory oversight, and a steady hum of litigation, in 2025 it seems like things might be changing for the beleaguered...more

Foley & Lardner LLP

Patent Fees Reimagined: Evaluating the Trump Administration's Value-Driven Fee Structure and Its Impact on Innovators

Foley & Lardner LLP on

The WSJ reports the Trump administration wants to charge patent holders 1% to 5% of their patent’s value to maintain the patent after grant. If implemented, this would mark a dramatic departure from the traditional flat-fee...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

Akin Gump Strauss Hauer & Feld LLP

Five FDA Takeaways from the FY26 Budget

On May 30, 2025, the Department of Health and Human Services released additional information regarding the Trump administration’s Fiscal Year (FY) 2026 budget request. The release of these FY26 budget materials is timely as...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

Venable LLP

Venable FDA Pulse: FDA at the 100-Day Mark of Trump Administration 2.0

Venable LLP on

Since returning to office for a second term, President Trump has taken steps to reshape federal agencies. Here, we discuss the significant changes that have occurred at the Food and Drug Administration (FDA or Agency) during...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

Arnall Golden Gregory LLP

Foreign Drug and Medical Device Manufacturers Under a Second Trump Administration: Increased Enforcement Scrutiny?

As discussions intensify about how the second Trump administration will reshape the regulatory landscape for U.S.-based life sciences firms, less attention has been given to the new administration’s regulatory impact abroad....more

Akin Gump Strauss Hauer & Feld LLP

2025 Perspectives in Private Equity: Health Care & Life Sciences

Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the 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

Skadden, Arps, Slate, Meagher & Flom LLP

Drug Pricing and Health Care Fraud Remain Key Issues

Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more

Morgan Lewis

UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded

Morgan Lewis on

In a not-so-unexpected turn of events, the Biden-Harris administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

Hogan Lovells on

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more

Hogan Lovells

Congress passes FY 2020 funding bill with tax benefits for energy, health care, and retirement plans

Hogan Lovells on

In a rare display of bipartisanship, after intense last minute negotiations between congressional leadership and the Executive Branch, President Donald Trump signed into law legislation passed last week by Congress to...more

Knobbe Martens

FDA Issues Draft Guidance for "Least Burdensome” Approach to Device Regulation

Knobbe Martens on

The FDA recently issued a draft guidance document intended to “to ensure that least burdensome principles are implemented for all device-related applications and interactions with FDA.”  The FDA provides this draft guidance...more

Seyfarth Shaw LLP

DOJ Places Website Rulemaking on the “Inactive” List

Seyfarth Shaw LLP on

Seyfarth Synopsis: Trump Administration’s first Unified Agenda reveals DOJ has placed web accessibility, medical equipment, and furniture rulemakings under Title II and III of the ADA on Inactive List....more

Snell & Wilmer

One in, Two Out: Potential FDA Uncertainty for Medical Device and Pharmaceutical Companies

Snell & Wilmer on

On January 30, 2017, President Trump signed an executive order requiring all governmental agencies to eliminate two regulations for every one issued. The Order, captioned “Reducing Regulation and Controlling Regulatory Costs”...more

18 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide