FDAs New Jersey District Office warns Raritan Pharmaceuticals about CGMP and other violations in its production of finished pharmaceuticals.
Federal Register notice: FDA seeks comments on an information collection extension for Medical Devices; Reports of Corrections and Removals 21 CFR Pa...
Attorney Stephen McConnell says a law review article properly faults FDAs position on truthful communication about off-label drug use.
FDA warns Adolfo Kaplan at the Pulmonary and Sleep Center of the Valley about objectionable conditions in the supervision and oversight of a clinical ...
The Securities and Exchange Commission files insider trading charges against two former employees and the spouse of a former employee of Ariad Pharmac...
FDA clears a Spineology 510(k) for the Rampart One Anterior Lumbar Interbody Fusion System.
Federal Register notice: FDA seeks comments on an information collection extension for Extralabel Drug Use in Animals 21 CFR Part 530 OMB Control Num...
Federal Register notice: FDA issues a priority review voucher to Biomarin for gaining approval of a rare pediatric disease product application for Bri...