FDA clears a Medtronic 510(k) for the Accurian RF ablation platform for use in radio frequency ablation of nerve tissues.
Bayer completes submission of a rolling NDA for its investigational prostate cancer drug darolutamide.
FDA issues Adamis Pharmaceuticals a Refusal to File letter on an NDA for its sublingual tadalafil product, indicated for treating erectile dysfunction...
FDA warns Spains Proandre SL about CGMP violations in its production of drugs.
FDA warns Pure Source about CGMP violations in its work as a contract manufacturer of homeopathic drugs.
Following a critical CBS 60 Minutes report that claimed FDA ignited the current opioid crisis, commissioner Scott Gottlieb says the agency will requir...
Federal Register notice: FDA issues a proposed rule to put into effect a final monograph for nonprescription, over-the-counter sunscreen drug products...
Federal Register notice: FDA makes available a draft guidance entitled Assessing the Effects of Food on Drugs in INDs and NDAs Clinical Pharmacology ...