News & Analysis as of

Regulatory Reform › Risk Management › Manufacturers

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

Bergeson & Campbell, P.C.

Clearing Regulatory Roadblocks: How Smarter Implementation Can Help Supply Chain Modernization

Bergeson & Campbell, P.C. on

On June 5, 2025, the Joint Economic Committee (JEC) of the U.S. Congress convened a hearing titled “Barriers to Supply Chain Modernization and Factor Productivity Enhancements.” Throughout the hearing, members and witnesses...more

Baker Donelson

Executive Orders on Domestic Production of Critical Medicines and Biological Research Security

Baker Donelson on

What Happened? The President signed two companion Executive Orders (EO) on May 5, 2025 that collectively signal a significant federal pivot toward (i) accelerating the domestic manufacture of pharmaceuticals deemed "critical"...more

Bergeson & Campbell, P.C.

Setting the Record Straight: New Chemical Review Needs Scientists

Bergeson & Campbell, P.C. on

On May 2, 2025, U.S. Environmental Protection Agency (EPA) Administrator Lee Zeldin announced the “[n]ext phase of organizational improvements to better integrate science into agency offices.” As part of this reorganization...more

Beveridge & Diamond PC

Twelve TSCA Developments to Expect in 2025 (Updated)

Beveridge & Diamond PC on

This alert was originally published on December 4, 2024, and has been revised based on recent developments. With the election of Donald Trump, the implementation of the Toxic Substances Control Act (TSCA) in 2025 will...more

Wiley Rein LLP

[Webinar] Chemical Regulation: 2025 Outlook - February 5th, 12:00 pm - 1:00 pm EST

Wiley Rein LLP on

As the second Trump Administration begins, significant shifts in the federal government’s approach to chemical regulation appear imminent. The main forces of change include the ongoing legal challenges to the Toxic Substances...more

King & Spalding

FDA FY 2021 Budget Foretells Medical Device Cybersecurity Reform

King & Spalding on

Increased premarket submission and post-market reporting requirements potentially on the horizon for high-tech devices. The Food and Drug Administration’s (“FDA’s”) budget proposal for FY2021 telegraphs FDA’s plan to seek new...more

Herbert Smith Freehills Kramer

TSCA Reform Enacted

Herbert Smith Freehills Kramer on

On June 22, 2016, President Obama signed the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Act), enacting a number of reforms to the Toxic Substances Control Act (TSCA) that are aimed to modernize and...more

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