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FDA releases the form FDA-483 with six observations from an inspection at Allentown, PA-based Central Admixture Pharmacy Services.[ Price : $8.95]
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 Shenzhen Superbio 510(k) for a point-of-care instrument intended for the qualitative detection of fentanyl in human u...