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Regulation Risk Management Enforcement Actions

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

K&L Gates LLP

Australia: Compensation Scheme of Last Resort (CSLR)

K&L Gates LLP on

Underfunded From Inception - The operator of CSLR has released the latest actuarial report commissioned on the scheme and the initial estimates of projected levies for 2025 / 26 (3rd levy period), triggering widespread...more

A&O Shearman

Zooming in on AI - #14: Enforcement of the AI Act

A&O Shearman on

The European Union Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. The AI Act establishes a risk-based approach to AI, prohibiting certain practices that are deemed unacceptable, such as social...more

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