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FDA clears an EndoChoice Holdings 510(k) for the Lumos with Adaptive Matrix Imaging, a proprietary imaging software system that is...[ Price : $8.95]
Federal Register Notice: FDA publishes a list of PMAs that have been approved.[ Price : $8.95]
FDA denies an American Herbal Products Association petition asking it to ensure that investigators link observations on FDA-483s i...[ Price : $8.95]
CDERs Larissa Lapteva says that less than 10% of IND applications are placed on clinical hold and most holds are cleared within a ...[ Price : $8.95]
Sunovion Pharmaceuticals files an NDA for SUN-101/eFlow (glycopyrrolate), an investigational treatment for the long-term, maintena...[ Price : $8.95]
Four CDER staffers call for new approaches to using in vivo in vitro correlations in drug development.[ Price : $8.95]
FDA tells Ocular Therapeutix that corrective actions detailed in a response to an inspection Form 483 appear to address the ten ob...[ Price : $8.95]
U.S. marshals, on behalf of FDA, seize more than 100 cases of products labeled as containing kratom from Nature Therapeutics LLC, ...