What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Already a member? Log in here
Esophageal Pre-Cancer Testing Gaining Greater Traction
How three companies are addressing screening challenges with tests that help improve chances of early detection
Already a member? Log in here
How Do You Solve a Problem Like AI Regulation?
How the current FDA AI/ML device regulations may be impeding innovation in the clinical lab
Already a member? Log in here
How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
Already a member? Log in here
Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
Already a member? Log in here