Regulatory Oversight, Trump Administration, Medical Devices

Five FDA Takeaways from the FY26 Budget

Akin Gump Strauss Hauer & Feld LLP on 6/3/2025

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

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

Venable LLP on 4/30/2025

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

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

Morgan Lewis on 2/3/2025

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

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

Skadden, Arps, Slate, Meagher & Flom LLP on 10/3/2020

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Likely FDA Impact of the Government Shutdown: Regulatory Submission Reviews, Inspections, and Research Projects

Hogan Lovells on 12/28/2018

The U.S. government shutdown that began December 22, 2018 affected only about a quarter of federal agencies, because most had already been funded for FY 2019. Unfortunately, FDA is one of the agencies with at least some...more

There'll Be Some Changes Made: President Signs Prescription Drug and Biologic User Fee Reauthorization Act

Hogan Lovells on 8/22/2017

On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs,...more