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Three Sheppard Mullin attorneys say FDA appears to be focusing on medical device enforcement of device-associated software that is...[ Price : $8.95]
FDA issues a final guidance describing CDERs program for the recognition of voluntary consensus standards related to drug quality....[ Price : $8.95]
FDA approves an Octapharma NDA for Balfaxar (prothrombin complex concentrate) for the urgent reversal of acquired coagulation fact...[ Price : $8.95]
Abbott recalls its Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles to be introduced into patients und...[ Price : $8.95]
Defender Pharmaceuticals files an NDA for its intranasally administered scopolamine gel for preventing motion-caused nausea and vo...[ Price : $8.95]
An FDA update clarifies the intended use of radiological computer-aided triage and notification devices for intracranial large ves...[ Price : $8.95]
FDA clears a Beckman Coulter 510(k) for its DxC 500 AU Chemistry Analyzer, an automated analyzer intended for use by small-to-medi...[ Price : $8.95]
FDA warns Stratus Biosystems that it is illegally marketing biological products whose manufacturing has significant deviations fro...