Federal Register notice: FDA issues an order to reclassify medical image analyzers, including CADe devices, for mammography breast cancer, ultrasound ...
FDA warns Gojo Industries that its Purell Advanced Hand Sanitizer products are unapproved new drugs that dont meet requirements for the tentative fina...
FDA denies a Persion petition asking that it restrict ANDA approval for generic products citing Zohydro ER as the reference-listed drug.
FDA releases a list of 15 potential drug safety signals that occurred in the fourth quarter of 2019.
Just-released approval documents shed light into how Sarepta was able to again win FDA approval for a Duchenne muscular dystrophy (DMD) drug after bei...
The Justice Department says Patient Services Inc. is paying $3 million to resolve false claims allegations that it coordinated with three drug compani...
FDA clears a Teleflex 510(k) for the Wattson Temporary Pacing Guidewire, a bipolar device designed for use during transcatheter aortic valve replaceme...
Two former Insys sales executives are sentenced to federal prison sentences for their role in a bribery and kickback scheme to promote use of the comp...