Haydar Celik, PhDExplore the scientific and regulatory challenges of developing blood tests for Alzheimer's disease, from biomarker selection and assay validation to clinical performance, AI-driven risk prediction, and FDA regulatory considerations.
Haydar Celik, PhDExplore 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.
Haydar Celik, PhDDiscover the regulatory challenges facing novel diagnostic technologies, including liquid biopsy, AI-driven diagnostics, digital pathology, multiplex biomarkers, and evolving FDA regulatory frameworks.