CDRH associate director for compliance and quality Keisha Thomas tells the RAPS Quality Conference about FDAs new Quality Management System Regulation...
A new Congressional Research Service report outlines FDAs evolving approach to regulating artificial intelligence-enabled medical devices and reviews ...
FDA issues an early alert regarding a potentially high-risk issue affecting certain patient circuits used with Baxter's Volara System.
FDA authorizes Felix Pharmaceuticals generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.
FDA sends a second complete response letter to Camurus regarding its NDA for Oclaiz (octreotide), an extended-release injection under review for the t...
The Department of Justice says a federal grand jury has indicted the co-owner of Floridas Pine Care Research Center and two staff members on charges t...
FDA approves labeling changes for Haleons OTC weight loss drug alli to warn of the rare risk of kidney injury associated with its use.
The United States Pharmacopoeia 2025 annual drug shortage report documents a reduction in the number of drug shortages but an increase in the time dur...
