FDA releases the form FDA-483 with six observations from an inspection at Allentown, PA-based Central Admixture Pharmacy Services.
Three Sheppard Mullin attorneys say FDA appears to be focusing on medical device enforcement of device-associated software that is promoted for uses b...
FDA issues a final guidance describing CDERs program for the recognition of voluntary consensus standards related to drug quality.
FDA approves an Octapharma NDA for Balfaxar (prothrombin complex concentrate) for the urgent reversal of acquired coagulation factor deficiency induce...
Abbott recalls its Amplatzer Steerable Delivery Sheath due to an increased risk for air bubbles to be introduced into patients undergoing procedures.
Defender Pharmaceuticals files an NDA for its intranasally administered scopolamine gel for preventing motion-caused nausea and vomiting in adults.
An FDA update clarifies the intended use of radiological computer-aided triage and notification devices for intracranial large vessel occlusion.
FDA clears a Beckman Coulter 510(k) for its DxC 500 AU Chemistry Analyzer, an automated analyzer intended for use by small-to-medium-sized labs.
