House Energy and Commerce Committee Republicans threaten to subpoena FDA if it continues to not produce foreign drug inspection information requested ...
FDA approves an Abbott PMA for its automated GLP systems Track, which is intended to support high-volume laboratory needs and maximize productivity.
FDA approves a Medtronic PMA for the PulseSelect Pulsed Field Ablation System for treating both paroxysmal and persistent atrial fibrillation.
Federal Register notice: FDA issues an order debarring Adam Michael Nagy for a period of 15 years from importing any drug into the U.S.
A Bloomberg Law article says FDA is doing little to address potentially violative social media drug ads.
The Massachusetts federal court approves a consent decree of permanent injunction against Pharmasol and its president for continuing to distribute adu...
FDA places a clinical hold on three CARsgen Therapeutics clinical trials due to chemistry, manufacturing and controls questions raised in a recent ins...
Four stakeholders submit specific technical concerns about an FDA draft guidance on topical ophthalmic drug quality considerations.