FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.
FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthalmic solutions.
Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation about prescription drugs...
FDA clears Sonic Incytes Velacur Determined Fat Fraction measuring tool.
Federal Register notice: FDA announces that it approved Incytes Opzelura (ruxolitinib) using a rare pediatric disease priority review voucher.
CDER director Patrizia Cavazzoni tells a drug regulatory conference that FDA is considering more opportunities for sponsors to learn about inspection ...
Two Cooley attorneys urge companies regulated by FDA to follow the guidelines in a 7/8 draft guidance on responding to misinformation carried on the I...
FDA clears a DeepWell Digital Therapeutics 510(k) for its biofeedback software development kit for use in over-the-counter treatments to relieve stres...
