The Drug & Device Law blog reviews cases that president Donald Trumps U.S. Supreme Court nominee Neil Gorsuch has decided and determines that he is su...
Federal Register Notice: FDA modifies the process by which it collects and post curricula vitae of advisory committee members.
FDA clears an Elekta 510(k) for its Venezia applicator for gynecological brachytherapy for use in treating advanced-stage cervical cancer.
The rogue FDA employees running an alternative Twitter handle @alt_fda have uploaded to the cloud an archive of inspection citations that date back ...
Medical device lobbying group AdvaMed continues to oppose adding unique device identifier information to insurance claims forms.
FDA says it is modifying the process on how it collects and posts curricula vitae (CVs) of advisory committee members so that they will be posted to i...
FDA issues Charleston Laboratories and Daiichi Sankyo a complete response letter on their NDA for CL-108 (hydrocodone, acetaminophen, promethazine), a...
House Energy and Commerce Committee chairman Greg Walden (R-OR) says a yet-to-be-announced health subcommittee hearing next week will take up a bill b...