Federal Register notice: FDA identifies a list of device accessories for which it believes general controls are sufficient to provide reasonable assur...
FDA alerts active pharmaceutical ingredient repackagers and distributors, and finished drug manufacturers that Sichuan Friendly Pharmaceutical Co. Lim...
FDA grants Brainsway de novo marketing clearance for its Deep Transcranial Magnetic Stimulation System for treating obsessive compulsive disorder.
Federal Register notice: FDA announces a 9/17 workshop entitled Science and Regulation of Live Microbiome-Based Products Used To Prevent, Treat, or Cu...
CDER director Janet Woodcock says FDA is looking for ways to expand use of real-world data in generating evidence of a drugs effectiveness.
FDA announces three initiatives called for in the MDUFA reauthorization to aid medical device development, innovation, and safety.
Attorney James Czaban reviews the steps FDA is taking to affect drug prices despite lacking specific direct authority in that area.
FDA releases inspection reports for 2016 and 2017 for Chinas Zhejiang Huahai Pharmacetical Co., maker of active pharmaceutical ingredient involved in ...