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Insights and Analysis

FDA DSCSA Public Meeting Highlights Interdependence of Trading Partners

03 October 2025

Insights and Analysis

FDA PreCheck meeting weighs how more clarity may help de-risk US manufacturing investments

03 October 2025

News

The DOJ’s Health Care Fraud Strike Force comes to Massachusetts: What this could mean for companies

01 October 2025

Insights and Analysis

CTGT/ATMP clinical trials surge in China, as first stem cell therapy product is conditionally authorized

30 September 2025

News

FDA finalizes computer software assurance guidance for production and quality system software

29 September 2025

News

What an FY 2026 federal government shutdown will mean for FDA

29 September 2025

Insights and Analysis

Shifting Borders, Securing Quality: Strategic Insights for Medical Device Companies Navigating Supplier Controls Through Near-Shoring and Friend-Shoring

26 September 2025

News

Section 232 tariff investigation: What medical device manufacturers and importers need to know

26 September 2025

Insights and Analysis

US and EU perspectives on the evolving nature of clinical requirements for biosimilars

26 September 2025

News

Cell & gene therapy clinical trials, development promoted in three new FDA guidance documents

25 September 2025

News

Japan’s conditional approval pathway offers regenerative medicines earlier market access

25 September 2025

News

Trade Enforcement in the Spotlight: What Vietnamese and Chinese companies - and multinationals with Asia-based supply chains - need to know if doing business with the U.S.

23 September 2025

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