FDA releases the FDA-483 with five observations from an inspection at Stokes Healthcare.
Stakeholders respond to FDA request for comment on an updated exposure-response analysis guidance.
FDA clears a RedDress Ltd 510(k) for its RD1 system, a device that allows health care providers to produce in real time in vitro whole blood clots for...
President Trump again criticizes drug companies over recent price hikes and promises to respond.
FDA releases its latest batch of Warning Letters that includes one medical product company Zhuhai United Laboratories.
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FDA publishes a draft guidance to help applicants write and format the Indications and Usage section of human drug labeling.