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Federal Register Notice: FDA makes available a draft guidance on Software as a Medical Device: Clinical Evaluation.[ Price : $8.95]
FDA publishes an International Medical Device Regulators Forum guidance on clinical evaluation of software as a medical device.[ Price : $8.95]
FDA approves a Medtronic PMA for its cardiac rhythm and heart failure devices and leads to be scanned in both 3 and 1.5 Tesla magn...[ Price : $8.95]
FDA accepts for review a Sunovion Pharmaceuticals NDA for SUN-101 (glycopyrrolate), a nebulized long-acting muscarinic antagonist ...[ Price : $8.95]
Stakeholders generally express support for FDA guidances controlling compounding drugs that are copies of an FDA-approved drug pro...[ Price : $8.95]
FDA updates a June safety communication calling attention to infections associated with Stӧckerts 3T Heater-Cooler System an...[ Price : $8.95]
Stakeholders pan and praise FDA attempts to regulate in vitro diagnostic tests based on next generation sequencing.[ Price : $8.95]
FDA places a clinical hold on an Aptose Biosciences Phase 1b clinical trial of APTO-253 in patients with hematologic cancers, requ...