A court has struck down the Food and Drug Administration’s attempt to extend its regulatory authority to clinical laboratory testing services. On March 31, 2025, in the consolidated cases American Clinical Laboratory...more
4/7/2025
/ Appeals ,
Civil Monetary Penalty ,
CLIA ,
Clinical Laboratories ,
Criminal Penalties ,
Department of Health and Human Services (HHS) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Laboratory Developed Tests ,
Medical Devices ,
Regulatory Agencies ,
Regulatory Authority ,
Statutory Interpretation
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial intelligence (AI) across the...more
3/26/2024
/ Artificial Intelligence ,
CDRH ,
Center for Biological Diversity ,
Center for Biologics Evaluation and Research (CBER) ,
Center for Drug Evaluation and Research (CDER) ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Popular ,
Public Health ,
Shareholders ,
White Papers