The federal court hearing a proton-pump inhibitor liability consolidated case is considering whether a former FDAer who was involved in regulating the...
FDA grants full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating certain adult patients with metastatic...
FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Maestro Brain Model, software that uses MRI images to conduct labeling, visualization, volumet...
Two stakeholders raise concerns about an FDA draft guidance on risk management programs to mitigate drug shortage potential.
The Colorado Society of Addiction Medicine says the labeling for buprenorphine products to treat opioid use disorder should be changed to recognize th...
Philips sends FDA additional comments on the agency discussion paper on strengthening cybersecurity practices for servicing medical devices.
Federal Register notice: FDA seeks comments on an information collection extension entitled Patent Term Restoration; Due Diligence Petitions; Filing, ...
Federal Register notice: FDA makes available a publication entitled Modifications to the List of Recognized Standards, Recognition List Number: 058....
