FDA advertising researchers say that drug companies still are not following recommendations from previous studies to improve communication of major st...
FDA approves an Otsuka Pharmaceutical NDA for mental disorder-treating Abilify MyCite (aripiprazole tablets with sensor) the first drug-device combin...
FDA issues a safety alert about illegal use of injectable silicone for body contouring and associated injuries and disfigurement that can result from ...
Federal Register notice: FDA classifies the automated indirect immunofluorescence microscope and software-assisted system into Class 2 (special contro...
CDRH associate director Suzanne Schwartz praises the progress medical device manufacturers have made in addressing cybersecurity issues.
FDA commissioner Scott Gottlieb cautions that the agency has not approved any products containing kratom and is taking action against dietary suppleme...
Researchers suggest ways to improve generic competition for previously unapproved drugs that have gained FDA approval under the agencys Unapproved Dru...
FDA warns RTI Surgical about multiple violations in its continuing manufacture of a bone graft product that is regulated as a drug and biologic.