FDA clears 510(k)s for four previously cleared Zeus Scientific tests with new indications to aid in diagnosing Lyme disease.
Federal Register notice: FDA seeks comments on a new information collection entitled Obtaining Information To Understand Challenges and Opportunities ...
FDA posts a guidance entitled Delayed Graft Function in Kidney Transplantation: Developing Drugs for Prevention.
FDA grants Orchard Therapeutics a Regenerative Medicine Advanced Therapy designation for the companys ex vivo autologous hematopoietic stem cell-based...
FDA posts a Form 483 after inspecting First Pharma Associates in Spokane, WA last month.
FDA approves an Intersect Ent PMA for its Straight Delivery System for use in placing its Propel Mini steroid-releasing implant in the ethmoid sinus.
Federal Register notice: FDA determines that Andrx Labs Fortamet (metformin hydrochloride) extended-release tablets was not withdrawn from sale for sa...
FDA issues a revised draft guide on Rare Pediatric Disease Priority Review Vouchers.