Federal Register notice: FDA seeks comments on a CDER/CBER framework for implementing a program to evaluate the potential use of real-world evidence i...
Federal Register proposed rule: FDA proposes to establish requirements for its medical device De Novo classification process.
Federal Register notice: FDA makes available a draft guidance entitled Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Gr...
AbbVie stops enrollment in the TAHOE trial, a Phase 3 study evaluating rovalpituzumab tesirine as a second-line therapy for advanced small-cell lung c...
CDER director Janet Woodcock selects Office of New Drugs deputy director Peter Stein as permanent director of the Office.
Indias Lupin Pharmaceuticals says FDA wrote up only "procedural" observations at three of its Mandideep generic drug manufacturing facilities.
FDA approves Genentechs Tecentriq (atezolizumab) for combination use with Avastin (bevacizumab), paclitaxel and carboplatin (chemotherapy) for the fir...
FDA clears an iCAD Inc. 510(k) for its ProFound AI, a cancer detection software solution for digital breast tomosynthesis that relies on artificial in...