FDA warns College Station, TX-based CardioQuip about multiple violations in its manufacture of a cardiac heater-cooler device in various configuration...
Federal Register notice: FDA announces that all outstanding hearing requests regarding certain potassium aminobenzoate products have been withdrawn an...
A National Academies committee recommends seven ways government and other stakeholders can improve the resilience of the U.S. medical products supply ...
FDA clears a Pearl 510(k) for its Second Opinion, an artificial intelligence radiologic detection aid intended to help dentists identify numerous comm...
CDER posts its FY 2021 GDUFA Science and Research Report that updates stakeholders on the development of innovative methodologies and more efficient t...
FDA asks stakeholders to comment on proposed changes to the drug quality metrics reporting program that has been tested in two pilots.
FDA says the computer software company PTC is recommending actions to be taken by medical device manufacturers who use PTCs Axeda agent or desktop ser...
An Illinois federal court approves a permanent injunction against Waukegan, IL-based dietary supplement maker Salud Natural Entrepreneur.