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News

Call for comments: FDA wants feedback on the distinct classification of existing device accessories into Class I

07 January 2026

News

Court issues preliminary injunction blocking West Virginia ban on certified colors

07 January 2026

Insights and Analysis

CMS issues mandatory Medicare models implementing Most Favored Nation drug pricing: GLOBE (Part B) and GUARD (Part D)

30 December 2025

News

Quality culture under QMSR: What FDA really wants—and how leaders can deliver

29 December 2025

News

FDA finalizes real-world evidence guidance for device sponsors, may consider more RWE in product reviews

22 December 2025

News

USDA updates guidelines for voluntary “Product of USA” label claims

19 December 2025

Insights and Analysis

FDA’s Digital Health Advisory Committee weighs guardrails for generative AI in mental health devices

18 December 2025

News

FDA opens a CMS-linked side door: Use of digital health devices before authorization under the TEMPO pilot

15 December 2025

News

FDA to publish guidance to improve the Rx to OTC switch application process

11 December 2025

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FDA says Agentic AI is used for premarket reviews, inspections, and more

09 December 2025

Insights and Analysis

When Culture Outpaces Compliance: A Wake-Up Call for US Medical Device Manufacturers

04 December 2025

Insights and Analysis

DOJ Subpoenas, Scientific Exchange, and Deference to Doctors – What We Are Watching

04 December 2025

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