FDA publishes two guidances describing a systematic system for evaluating drug-drug interactions and communicating about them in labeling.
The Philadelphia Inquirer reports that FDA is expected to rule later this year on a proposed new indication to treat uterine fibroids in premenopausal...
ABH Nature's, ABH Pharma and Stocknutra.com recalls its dietary supplement products manufactured and sold between 1/2013 to 11/2019.
FDA clears a Baze 510(k) for its at-home blood collection process and its use to assess blood nutrient status.
FDA gives Medtronic approval to proceed with an IDE trial (PULSED AF) to evaluate the safety and effectiveness of its PulseSelect Pulsed Field Ablatio...
Wisconsin cardiologist Nalini Rajamannan contacts FDA commissioner Stephen Hahn over the agencys decision not to provide information to patients who w...
Federal Register notice: FDA seeks comments on an information collection extension for Reporting Associated With Animal Drug and Animal Generic Drug U...
Federal Register notice: FDA seeks comments on an information collection extension for Electronic Products 21 CFR Parts 1000 Through 1050.