Follea says it has submitted to FDA a de novo application for its Minoxidil Response Test.
President Trump declares the opioid abuse crisis in the U.S. to be a public health emergency while briefly mentioning FDAs role in the effort.
FDA accepts for review a Genentech supplemental BLA for Avastin (bevacizumab) for its use in combination with chemotherapy, followed by Avastin alone,...
Federal Register notice: FDA makes available a draft guidance entitled Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Adm...
FDAs Los Angeles District issues a nine-page Warning Letter to an OTC drug manufacturer that allegedly makes topical pain drugs in the kitchen of a ho...
Four congressional Democrats introduce a bill to require HHS to negotiate prices for Medicare Part D covered drugs.
FDA issues two draft guidances on a systematic, risk-based approach to evaluating drug-drug interactions.
Federal Register notice: FDA makes available two draft guidances entitled In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies ...