[ Price : $8.95]
FDA clears an Envisionit Deep AI 510(k) for its artificial intelligence (AI)-assisted chest x-ray device, Radify Triage, for triag...[ Price : $8.95]
Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for 22 medical Covid-related medical devices a...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Good Manufacturing Practice for Active Pharmaceutical Ingre...[ Price : $8.95]
CBER says Lewisburg, TN-based Vitacell Biologics is illegally marketing cellular and exosome products.[ Price : $8.95]
FDA releases the form FDA-483 with two inspection observations issued to Columbus, OH-based STAQ Pharma of Ohio.[ Price : $8.95]
CBER executives say FDA is aware of a relatively small number of cases in which people treated with CAR-T products developed secon...[ Price : $8.95]
FDA issues a finalized guidance on updating ANDA labels following revisions to the reference-listed drug label.[ Price : $8.95]
CDER and CBER say they have accepted the first artificial intelligence, digital health technology, and neuroscience project in the...