FDA clears a Visura Technologies 510(k) for its TEE Camera Assist Device, a single-use disposable camera that attaches to a transesophageal echocardio...
Federal Register notice: FDA announces an 8/7 Antimicrobial Drugs Advisory Committee meeting.
FDA publishes a draft guidance to help applicants write and format the Indications and Usage section of human drug labeling.
CDRH director Jeffrey Shuren says FDA is leading a group of international medical device regulators who are developing policies to regulate software a...
The 6th Circuit Court of Appeals says a suit alleging failure to provide a medication guide is preempted by federal law.
FDA releases its latest batch of Warning Letters that include Foshan Jinxiong Technology and Sichuan Friendly Pharmaceutical Co.
Fagron Sterile Services recalls two lots of neostigmine methylsulfate 5ml syringes after a confirmed customer complaint that some syringe units are in...
The BMJ reports on a Science investigation into potential conflicts of interest with some FDA advisory committee members.