FDA says health care professionals and patients should not to use drug products intended to be sterile that were produced by Promise Pharmacy, Palm Ha...
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Federal Register notice: FDA makes available a draft guidance entitled Developing and Labeling In Vitro Companion Diagnostic Devices for a Specific Gr...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.
Federal Register notice: FDA makes available a draft guidance entitled Bacterial Risk Control Strategies for Blood Collection Establishments and Trans...
FDA clears a Meridian Bioscience 510(k) for its new Alethia CMV Molecular Amplification Test.