FDA Related News

Medical Devices

FDA Extends PMA Review for Nuvectras Urological Device

FDA extends its review of a Nuvectra PMA for its Virtis Sacral Neuromodulation system, indicated for use in treating chronic urinary retention and sym...

Medical Devices

FDA Clears XableCath Peripheral Crossing Catheter

FDA clears a XableCath 510(k) for its Peripheral Crossing Catheters, intended for use to cross challenging lesions in both arterial chronic total occl...

Human Drugs

FDA Approves First Advair Diskus Generic

FDA approves Mylans application for the first generic form of GlaxoSmithKlines Advair Diskus asthma inhalation powder.

Human Drugs

FDA Generic Drug Inspections, Enforcement Down: Bloomberg News

A year-long Bloomberg News investigation highlights concerns that FDA generic drug surveillance inspections have been dropping while the number of app...

Human Drugs

FDA Warns Miami University Fertility Center

FDA sends University of Miami Reproductive and Fertility Center a Warning Letter for significant deviations from the regulations for human cells, tiss...

Human Drugs

Cook Medical/Zelegent Snoring Device Cleared

FDA clears a Cook Medical and Zelegent 510(k) for the Elevo Kit Snoring Intervention Device.

Human Drugs

Innate Pharma Fast Track for Sezary Syndrome

FDA grants Innate Pharma a fast track designation for IPH4102 and its use in treating adult patients with relapsed or refractory Sezary syndrome who h...

FDA Activities to Expand Real-World Evidence Use

FDA commissioner Scott Gottlieb outlines ways the agency hopes to expand use of real-world data and real-world evidence.

Human Drugs

CGMP Violations at Hangzhou Guoguang Touring Commodity

FDA warns Chinas Hangzhou Guoguang Touring Commodity Co. about CGMP violations in producing finished pharmaceuticals as a contract manufacturer.

Ad Price Disclosure Ill-Conceived, Illegal: WLF

Attorney Howard Dorfman says the CMS proposal to require companies to include the prescription drug wholesale acquisition price in DTC ads is ill-conc...