FDA says a Philips Respironics software correction for several ventilators was a Class 1 recall.
FDA releases the form FDA-483 with seven observations issued following an inspection at the Lorton, VA-based Annovex Pharma outsourcing facility.
FDA approves GE HealthCares Flyrcado (flurpiridaz F 18) injection, a positron emission tomography myocardial perfusion imaging agent for detecting cor...
FDA approves a Siemens Healthineers PMA for its tomosynthesis or three-dimensional breast imaging technology for its Mammomat B.brilliant mammography ...
The journal Science and other FDA watchers question why FDA does not place a clinical hold on Cassava Sciences investigational Alzheimers drug simufil...
Federal Register notice: FDA makes available a final guidance entitled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical ...
Federal Register notice: FDA determines that U.S. Antibiotics Augmentin XR (amoxicillin; clavulanate potassium) extended-release tablet was not withdr...
FDA grants fast-track designation to an investigational Volastra drug intended to treat some cases of ovarian cancer
