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Federal Register notice: FDA seeks comments on an information collection extension entitled Medical Devices: Current Good Manufact...[ Price : $8.95]
A new research article by FDA and European regulators finds their good clinical practice inspection processes to be equivalent, wh...[ Price : $8.95]
FDA classifies as Class 1 a recent Medtronic recall of its Cobalt/Crome implantable cardioverter defibrillators and resynchronizat...[ Price : $8.95]
A new FDA report on Covid-19 activities notes that the agency is initiating a new inspection planning system that will be more eff...[ Price : $8.95]
A just-completed FDA inspection of Sun Pharmaceutical Industries Punjab, India manufacturing facility leads to a six-item Form FDA...[ Price : $8.95]
FDA sends India-based Cipla Ltd. a two-item Form FDA-483 after a recent inspection at its Madhya Pradesh, India manufacturing plan...[ Price : $8.95]
FDA revises a Pfizers emergency use authorization for Paxlovid (nirmatrelvir co-packaged with ritonavir) for treating mild-to-mode...[ Price : $8.95]
FDA clears a Visibly 510(k) for its Visibly Digital Acuity Product (VDAP), an at-home digital vision testing platform for determin...