CDER Office of Generic Drugs associate director Sarah Ibrahim discusses the first-year output of the new Generic Drug Cluster involving several regula...
FDA issues a safety alert on a cybersecurity risk with Medtronics MiniMed 600 Series Insulin Pump System (e.g., MiniMed 630G and MiniMed 670G).
Federal Register notice: FDA seeks patient advocate applications to participate under its collaboration with the Clinical Trials Transformation Initia...
Federal Register notice: FDA determines that Hoffmann-La Roches Endep (amitriptyline HCl) was not withdrawn from sale for safety or effectiveness reas...
Roche gains FDA 510(k) clearance for the cobas pure integrated solutions, the next generation of its cobas diagnostics platform.
FDA clears a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software.
Vanda Pharmaceuticals agrees to settle an off-label marketing case for $11.5 million.
A federal jury convicts former clinical researcher for making a false statement to a government investigator related to her role in a clinical trial t...
