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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.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Developing and Labeling In Vitro Companion Diagnostic Devic...[ Price : $8.95]
AbbVie stops enrollment in the TAHOE trial, a Phase 3 study evaluating rovalpituzumab tesirine as a second-line therapy for advanc...[ Price : $8.95]
CDER director Janet Woodcock selects Office of New Drugs deputy director Peter Stein as permanent director of the Office.[ 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...