In summer 2019, the Congressional Appropriations Committee voted to reinstate a rider to the Consolidated Appropriations Act that prohibits the FDA from reviewing clinical applications in which a human embryo would be intentionally created or modified to include a heritable genetic modification. Prior to this vote,...
Category: FDA Regulation
Laboratory Developed Tests Under Scrutiny: FDA Questions Validity and Utility of Oncotype Dx and Prolaris Tests for Personalized Cancer Treatment
posted by: Katherine Drabiak, J.D.
March 8, 2016
In November 2015, FDA published a startling report, The Public Health Evidence for FDA Oversight of Laboratory Developed Tests, which enumerated serious concerns with the current framework it uses to oversee laboratory developed tests (LDTs). LDTs are tests used by physicians to diagnose disease, predict...