Federal Register notice: FDA seeks comments on an information collection extension for Guidance for Industry on E6 (R2) Good Clinical Practice; Intern...
FDA clears a Bardy Diagnostics 510(k) for its 14-Day version of the Carnation Ambulatory Monitor, a P-wave heart monitor.
Endo International files a BLA for collagenase clostridium histolyticum for treating cellulite in the buttocks.
FDA publishes two guidances relating to humanitarian use device designations and humanitarian device exemptions.
Federal Register notice: FDA submits to OMB an information collection extension for NDA patent submission and listing requirements.
Federal Register proposed rule: FDA proposes to add five additional bulk drug substances to its drug compounding list.
FDA funds VeraSci research into a virtual reality functional capacity assessment tool.
The Justice Department says Mallinckrodt is paying $15.4 million to resolve allegations that it paid illegal kickbacks to doctors to induce Medicare A...