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.
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
Lee Fleisher, MD, advocates for clearer interpretation of test results by medical laboratory scientists
The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation