FDA releases its latest batch of Warning Letters that includes Acino Products, Chemland, Jiangsu JDC Medical Devices and Silfradent.
FDA warns CPAPNEA about multiple violations in its manufacturing of Optipillows.
Public Citizen calls on FDA and drug industry trade associations to publicly identify all drugs that are in shortage due to the Covid-19 epidemic.
FDA clears an FX Shoulder 510(k) for its Glenoid Baseplate with a Central Screw and 32mm Glenosphere and Humeral Cups for reverse shoulder arthroplast...
As the coronavirus outbreak grows in the U.S., including two deaths over the weekend related to the illness, FDA implements a new policy to permit cer...
Federal Register notice: FDA determines that CIS Bio Internationals Neo Tect Kit was not withdrawn from sale for safety or effectiveness reasons.
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Mercks psoriasis drug Ilumya (tildrakizumab).
FDA releases a final guidance on Bone Anchors Premarket Notification (510(k)Submissions.