Three Hyman Phelps attorneys question as irresponsible FDAs decision to issue a safety communication about non-invasive prenatal tests without providi...
The Justice Department says a federal jury returned guilty verdicts for a former Florida pain doctor and a former Insys sales representative in a heal...
FDA grants a de novo authorization to Angle plc for its Parsortix system for use in harvesting cancer cells from metastatic breast cancer patient bloo...
FDA says research indicates that collaborative good clinical practice inspections by FDA and the European Medicines Agency provide comparable results.
Two former FDA attorneys say proposed BLOCKING legislation will not have its intended effect of accelerating generic drug entry into the marketplace.
Harvard Medical School researchers call for major changes to dietary supplement listing proposed legislation.
FDA grants fast track designation for Elevation Oncologys seribantumab for the tumor-agnostic treatment of advanced solid tumors that harbor NRG1 gene...
FDA clears an inHeart 510(k) for its inHeart Models software suite that enables 3D visualization and analysis of anatomical structures for pre-procedu...