Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within the content of direct-to-consumer radio and TV ads w...
Attorney Jake Leys says MDUFA 6 reauthorization has moved from negotiations into writing the commitment letter that spells out all that FDA and the me...
FDA approves GSK's Jideytro (zidesamtinib) for certain adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer.
FDA investigators cite contract research organization Cliantha Research over data integrity, documentation and clinical research deficiencies followin...
A citizen petition urges FDA to establish a regulatory framework for implantable brain-computer interfaces designed to expand human sensory perception...
An analysis by PharmaVoice says FDA could remain without a Senate-confirmed commissioner for months as political and procedural hurdles complicate eff...
FDA acting commissioner Kyle Diamantas uses a Fox News editorial to tout agency steps he says are providing new jobs for American workers and protecti...
FDA names Dexcom as the first participant in its new Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot.
