CDER says its more extensive testing found NDMA in only eight of 16 metformin samples in which it was found by a private laboratory.
FDA clears a SoftWave Tissue Regeneration Technologies 510(k) for using its SoftWave technology for treating superficial, partial-thickness, second-de...
FDA issues a revised and updated draft guidance on pharmacokinetic study design and analysis for patients with impaired renal function.
Sen. Ted Cruz and 19 other senators call on FDA to order the abortion drug Mifeprex off the U.S. market.
FDA accepts for priority review an Athenex NDA for oral paclitaxel and encequidar for treating metastatic breast cancer.
FDA grants Alphamab Oncology an orphan drug designation for KN046, a recombinant humanized antibody for treating thymic epithelial tumors.
Aerospace engineer Robert Zubrin writes in National Review that FDA is an over-regulating federal bureaucracy gone mad.
FDA commissioner Stephen Hahn removes associate commissioner for external affairs John Wagner as part of the purge to right the ship in the wake of Ha...