The United States Pharmacopeia sets a 90-day comment period for a proposed policy change relating to publication of reporting thresholds in drug produ...
Sarepta wants to schedule a meeting with FDA to discuss next steps following a complete response letter for its Duchenne muscular dystrophy drug golod...
The FDA Pediatric Advisory Committee and Risk Management Advisory Committee schedule a joint meeting 9/26-27 to look at pediatric safety review for Ox...
Turner Scientific asks FDA to adopt and issue a guidance the company drafted on routine testing of drugs and biologics for ototoxic potential.
FDA approves a Boston Scientific PMA supplement for its ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation System to be used in a fu...
FDA sends Dr. Reddys Laboratories an eight-observation Form FDA-483, the third inspection form in six weeks for one of its facilities in India.
FDA releases its latest batch of Warning Letters that includes Deva Holding, Polymer Technology Systems and TG United.
FDA sends Vanda Pharmaceuticals a complete response letter on supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder.