Sen. Richard Blumenthal (D-CT) introduces a bill (S 1656) to amend the federal Food, Drug, and Cosmetic Act to provide cybersecurity protections for m...
Four stakeholder groups praise FDA efforts in publishing the Biosimilar User Fee Agreement Statement of Work before the 10/1 anticipated agreement app...
Public Citizen says the MINT trial violates ethical principles and should be suspended until more work is done on its protocol.
FDA Webview editor Jim Dickinson analyzes a Washington Post article on the Essure contraceptive device and sees an ingrained pattern of ossified CDRH ...
FDA grants AstraZeneca and MedImmune a breakthrough therapy designation for Imfinzi (durvalumab) for treating patients with locally-advanced, unresect...
Amgen files a supplemental BLA for Prolia (denosumab) for treating patients with glucocorticoid-induced osteoporosis.
Federal Register notice: FDA classifies as a Class 2 (special controls) medical device the oral removable palatal space occupying device for weight ma...
Federal Register notice: FDA classifies as a Class 2 (special controls) medical device the cranial motion measurement device.