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Biden Administration Trump Administration 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

Sheppard Mullin Richter & Hampton LLP

“Buy American” Update: Essential Medicines May Continue to Come From Abroad (For Now)

The Biden Administration has taken (at least temporarily) the teeth out of a Trump-era Executive Order that directed the government to “Buy American” for essential drugs and medical devices. President Trump’s August 2020...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UPDATE: Trump Administration’s Midnight Rulemaking to Exempt Certain Class I and II Devices from 510(k) Requirement Rescinded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administration’s Department of Health and Human Services (HHS) and the US Food and Drug Administration (FDA) rescinded a notice issued by the Trump administration’s HHS...more

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