FDA Not On Board With Alexander's Idea Of Separate Agency For LDTs

FDA believes creating a new regulatory agency to oversee laboratory-developed tests would “undermine efforts to advance precision medicine” and create unnecessary bureaucracy, an agency spokesperson told Inside Health Policy after Senate health committee Chairman Lamar Alexander (R-TN) floated such a proposal at a hearing focused on LDT oversight Tuesday (Sept. 20). Alexander had said in prepared remarks Tuesday that if FDA finalizes its draft guidance, which would bring LDTs under medical device regulations, patients could lose access to tests...