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FDA releases the form FDA-483 with seven observations issued following an inspection at the Lorton, VA-based Annovex Pharma outsou...[ Price : $8.95]
FDA approves GE HealthCares Flyrcado (flurpiridaz F 18) injection, a positron emission tomography myocardial perfusion imaging age...[ Price : $8.95]
FDA approves a Siemens Healthineers PMA for its tomosynthesis or three-dimensional breast imaging technology for its Mammomat B.br...[ Price : $8.95]
The journal Science and other FDA watchers question why FDA does not place a clinical hold on Cassava Sciences investigational Alz...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Electronic Systems, Electronic Records, and Electronic Sig...[ Price : $8.95]
Federal Register notice: FDA determines that U.S. Antibiotics Augmentin XR (amoxicillin; clavulanate potassium) extended-release t...[ Price : $8.95]
FDA grants fast-track designation to an investigational Volastra drug intended to treat some cases of ovarian cancer[ Price : $8.95]
Two trade associations that oppose FDA regulation of laboratory-developed tests ask a Texas federal court to grant summary judgmen...