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Regulatory Reform › Executive Orders › 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

Morgan Lewis

Navigating Uncertainty in US FDA’s Center for Devices and Radiological Health Regulation of Medical Devices

Morgan Lewis on

The past six months at the US Department of Health and Human Services and the US Food and Drug Administration’s Center for Devices and Radiological Health have seen a fluctuating workforce size, a slew of new executive...more

Morgan Lewis - As Prescribed

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Morgan Lewis - As Prescribed on

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Skadden, Arps, Slate, Meagher & Flom LLP on

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Faegre Drinker Biddle & Reath LLP

The Effects of HHS Workforce Reductions, Tariffs on Pharma, the ‘Pill Penalty’ and More

Faegre Drinker Biddle & Reath LLP on

With the rapidly evolving regulatory landscape, staying on top of the latest updates is crucial for companies in biopharma and medical devices. In this briefing, we highlight recent regulatory and legislative developments...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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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 Q2 2024 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

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