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Federal Register notice: FDA makes available a final guidance on IRB reviews of individual patient expanded access requests.[ Price : $8.95]
FDA posts test performance data from four antibody test kits from an independent performance validation study effort with the Nati...[ Price : $8.95]
FDA grants AlgoTherapeutix an orphan drug designation for ATX01 (topical amitriptyline) for treating erythromelalgia.[ Price : $8.95]
FDA reissues certain emergency use authorizations to identify specific respirators that can be decontaminated for reuse.[ Price : $8.95]
A new FDA drug quality annual report finds that the agency in 2019 performed 1,258 drug quality surveillance inspections, with 42%...[ Price : $8.95]
CDER Office of Antimicrobial Products deputy director John Farley is named permanent director.[ Price : $8.95]
FDA posts a guidance on a temporary Policy to make it easier for drug firms to distribute drug samples During the Covid-19 public ...[ Price : $8.95]
FDA approves an Abiomed IDE to start an early feasibility study with a first-in-human trial of the 9 French Impella Expandable Car...