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FDA releases summaries from three PDUFA 7 workgroup and subgroup discussions at the end of 2020.[ Price : $8.95]
The Government Accountability Office recommends additional things that FDA and other federal agencies should be doing as part of t...[ Price : $8.95]
FDA says a Boston Scientific recall of EMBLEM defibrillator electrodes due to potential fracturing is Class 1.[ Price : $8.95]
FDA clears an Inovytec 510(k) to market its Ventway Sparrow ventilators in the U.S.[ Price : $8.95]
FDA warns American Global Health Group that it is marketing misbranded unapproved new drugs.[ Price : $8.95]
FDA clears NeurMedix to begin a pivotal Phase 3 clinical trial to evaluate its lead (XXX DELETE XXX) drug candidate, NE3107 in Alz...[ Price : $8.95]
Eagle Pharmaceuticals says it is responding to an FDA complete response letter for its vasopressin ANDA.[ Price : $8.95]
FDA denies a Public Citizen petition asking it to rescind PMA approval for Genzymes Seprafilm but orders Warning and labeling chan...