FDA Related News

Human Drugs

FDA Enhancing Orange Book: Gottlieb

FDA issues a new drug marketing status notification guidance, an initial step in enhancements to the Orange Book.

Medical Devices

Kurin PIV18 Peripheral IV Set Cleared

FDA approves a Kurin 510(k) for its Kurin PIV18 peripheral IV configuration with an extension set, which is intended for use with infusions.

Human Drugs

Tris Pharma Recalls 3 Infant Ibuprofen Lots

Tris Pharma recalls three lots of infants ibuprofen concentrated oral suspension, 50 mg per 1.25 mL, because the products have been found to potential...

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

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.