Chevron Deference Overturned: What's Next for FDA's LDT Oversight

Haydar Celik, PhD

Published on: 02/07/2024

Explore how the Supreme Court's Chevron deference decision could reshape FDA oversight of laboratory developed tests (LDTs), regulatory authority, compliance strategies, and the future of diagnostic innovation.

Regulatory Reflections

Regulatory Hurdles for Novel Diagnostic Technologies

Haydar Celik, PhD

Published on: 22/06/2024

Discover the regulatory challenges facing novel diagnostic technologies, including liquid biopsy, AI-driven diagnostics, digital pathology, multiplex biomarkers, and evolving FDA regulatory frameworks.

The Diagnostic Edge