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Federal Register notice: FDA makes available a draft guidance entitled Providing Regulatory Submissions in Alternate Electronic Fo...[ Price : $8.95]
Four stakeholders raise varying concerns with the FDA/HHS proposal to allow some state drug importation programs.[ Price : $8.95]
FDA again rejects Intarcia Therapeutics ITCA 650 exenatide implant intended to treat Type 2 diabetes.[ Price : $8.95]
FDA posts two documents on the potential shortage of personal protective equipment for healthcare organizations and staff during t...[ Price : $8.95]
FDA grants accelerated approval for Bristol-Myers Squibbs Opdivo and Yervoy in hepatocellular carcinoma patients who were previous...[ Price : $8.95]
FDA approves a Roche PMA for its CINtec Plus Cytology as a biomarker-based triage test for women whose primary cervical cancer scr...[ Price : $8.95]
Lawmakers at an FDA appropriations hearing criticize commissioner Stephen Hahn about delays in coordinating laboratory-developed t...[ Price : $8.95]
FDA issues an ICH guidance on limiting elemental impurities in drug products.