FDA Related News

Medical Devices

Joint Security Plan on Cybersecurity Challenges

A Healthcare and Public Health Sector Coordinating Council working group releases a Joint Security Plan with recommendations to address cybersecurity ...

Human Drugs

FDA Expanded Access Pilot Coming

FDA commissioner Scott Gottlieb says FDA is looking at a process to help patients navigate the expanded access protocol and put the agency in direct c...

Human Drugs

Merck Gains Breakthrough Status for Pneumococcal Vaccine

FDA grants Merck a breakthrough therapy designation for its V114 investigational 15-valent pneumococcal conjugate vaccine, indicated for preventing in...

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...

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.