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Human Drugs

FDA Signals NDA Path for Virpax Nasal Anti-viral Barrier

FDA tells Virpax Pharmaceuticals that it can proceed with additional research on MMS019, a high-density molecular masking spray under development for ...

Intended Use Final Rule Analyzed

Attorney Jeffrey Shapiro says the FDA final regulation on intended use is a modest improvement over past practice.

Medical Devices

FDA Says Purple Wristbands, Bracelets Only for DNR

FDA recommends hospitals standardize their use of purple medical device bracelets or wristbands to only signify Do Not Resuscitate status.

Human Drugs

Tempus PMA for xT-Onco Assay

Tempus files a PMA for its broad-panel DNA sequencing xT-Onco assay, an in vitro diagnostic device intended to assist healthcare professionals with da...

Biologics

Utah Cord Bank Hit with Warning Letter

A February FDA inspection at Utah Cord Bank (also known as Utah Cell Bank) determines that the firms cell products StemVive and StemMaxx are unapprove...

Medical Devices

Globus Medical Excelsius Imager Cleared

FDA has cleared a Globus Medical 510(k) for the Excelsius3D, an intraoperative three-in-one imaging system.

Human Drugs

12 Observations on Imprimis FDA-483

FDA releases the FDA-483 with 12 observations from an inspection at the Imprimis drug compounding facility in Lakewood, NJ.

Medical Devices

FDA Prioritizing Medical Device Cybersecurity: Post

MedTech Dive says FDA is seeking legislative authorities to prioritize medical device cybersecurity by imposing new requirements on manufacturers.

Medical Devices

QS Issues Found in Tianjin Bolang Science Tech. Inspection

FDA warns Chinas Tianjin Bolang Science Technology Development Co. about Quality System violations in its production of three medical devices.

Medical Devices

BlackBerry QNX Cybersecurity Vulnerabilities

FDA says it is working with federal agencies, medical device manufacturers, and the private sector to resolve cybersecurity vulnerabilities in a Black...