FDA researchers highlight the varying participation rates of women in various types of cardiovascular clinical trials.
FDA approves a U.S. WorldMeds NDA for Lucemyra (lofexidine hydrochloride) for mitigating withdrawal symptoms in adults who have abruptly discontinued ...
IQVIA, an FDA data vendor, says it has corrected a weight-conversion factor problem identified by FDA in data on fentanyl sales.
FDA updates a safety alert for all gadolinium-based contrast agents for MRIs to include an agency-approved new patient Medication Guides.
FDA accepts the EndoLogic cardiac safety trial for renzapride in gastroparesis patients and says there was no evidence of QTc prolongation in EKG find...
FDA clears a Ventripoint Diagnostics 510(k) for its VMS+ machine with a four-chamber heart analysis system, intended for use in the analysis of ejecti...
Federal Register notice: FDA announces a 7/18-19 Blood Products Advisory Committee.
FDA clears a BacterioScan 510(k) for its 216Dx Urinary Tract Infection detection system.