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FDA issues a safety communication on reprocessed duodenoscopes after interim study results show higher-than-expected contamination...[ Price : $8.95]
CDER deputy Center director for clinical science Bob Temple accepts a new position at the Center Office of New Drugs senior advis...[ Price : $8.95]
Indias Lupin Pharmaceuticals says FDA wrote up only "procedural" observations at three of its Mandideep generic drug manufacturing...[ Price : $8.95]
FDA approves Genentechs Tecentriq (atezolizumab) for combination use with Avastin (bevacizumab), paclitaxel and carboplatin (chemo...[ Price : $8.95]
FDA clears an iCAD Inc. 510(k) for its ProFound AI, a cancer detection software solution for digital breast tomosynthesis that rel...[ Price : $8.95]
FDA says health care professionals and patients should not to use drug products intended to be sterile that were produced by Promi...[ Price : $8.95]
Federal Register notice: FDA seeks comments on a CDER/CBER framework for implementing a program to evaluate the potential use of r...[ Price : $8.95]
Federal Register proposed rule: FDA proposes to establish requirements for its medical device De Novo classification process.