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CDER Division of Hematologic Malignancies 2 division director Nicole Gormley is named acting associate director for oncology endpo...[ Price : $8.95]
FDA grants Intelligent Ultrasound a de novo marketing authorization for its artificial intelligence ScanNav Anatomy Peripheral Ner...[ Price : $8.95]
Federal Register notice: FDA sends to OMB a proposed information collection entitled Annual Summary Reporting Requirements Under t...[ Price : $8.95]
For the second time in a year, FDA inspects contract manufacturer Catalents Brussels, Belgium, manufacturing facility.[ Price : $8.95]
Federal Register notice: FDA extends the comment period for a 6/28 proposed rule entitled Nonprescription Drug Product With an Add...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for the Breakthrough Devices Program Guidanc...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Multiple Endpoints in Clinical Trials.[ Price : $8.95]
Federal Register notice: FDA extends the period before it intends to begin enforcing a statutory 5% limit on distribution of compo...