Four stakeholders raise varying concerns with the FDA/HHS proposal to allow some state drug importation programs.
FDA again rejects Intarcia Therapeutics ITCA 650 exenatide implant intended to treat Type 2 diabetes.
FDA posts two documents on the potential shortage of personal protective equipment for healthcare organizations and staff during the Covid-19 outbreak...
FDA grants accelerated approval for Bristol-Myers Squibbs Opdivo and Yervoy in hepatocellular carcinoma patients who were previously treated with Baye...
FDA approves a Roche PMA for its CINtec Plus Cytology as a biomarker-based triage test for women whose primary cervical cancer screening results are p...
Lawmakers at an FDA appropriations hearing criticize commissioner Stephen Hahn about delays in coordinating laboratory-developed tests and the agencys...
FDA issues an ICH guidance on limiting elemental impurities in drug products.
Federal Register notice: FDA announces a 5/4 public workshop entitled FY 2020 Generic Drug Regulatory Science Initiatives.