FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Abiomeds Impella Heart Pump Gets Breakthrough

[ Price : $8.95]

FDA grants a breakthrough designation to Abiomeds Impella ECP expandable percutaneous heart pump.

Slight Drop in Number of Drug Manufacturing Sites: Report

[ Price : $8.95]

The CDER State of Pharmaceutical Quality report for FY 2020 documents a slight decrease in the number of drug manufacturing sites ...

FDA Signals NDA Path for Virpax Nasal Anti-viral Barrier

[ Price : $8.95]

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

Intended Use Final Rule Analyzed

[ Price : $8.95]

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

FDA Says Purple Wristbands, Bracelets Only for DNR

[ Price : $8.95]

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

Tempus PMA for xT-Onco Assay

[ Price : $8.95]

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

Utah Cord Bank Hit with Warning Letter

[ Price : $8.95]

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

Globus Medical Excelsius Imager Cleared

[ Price : $8.95]

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

12 Observations on Imprimis FDA-483

[ Price : $8.95]

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

FDA Prioritizing Medical Device Cybersecurity: Post

[ Price : $8.95]

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