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.
FDA says that a reverse-FOIA lawsuit seeking to shield an unnamed company attorneys identity in connection with a Form FDA-483 should be dismissed.
The 3rd Circuit Court of Appeals agrees with a Pennsylvania federal court that FDA failed to state the offense under the law in charging generic drug ...
FDA warns Stratus Biosystems that it is illegally marketing biological products whose manufacturing has significant deviations from CGMP requirements.
FDA says the Teva and Apotex generic forms of Vandas Hetlioz do not violate labeling requirements or raise safety concerns due to some different eleme...
FDA approves a Tarsus Pharmaceuticals NDA for Xdemvy (lotilaner ophthalmic solution) 0.25% for treating Demodex blepharitis, an eyelid disease caused ...
CDRH announces new standards recognized by the agency to improve medical device sterilization.
An FDA podcast reports ways in which the CURE ID app is being expanded beyond infectious diseases.
