RAPS

FDA warns Integra LifeSciences over endotoxin testing, complaint investigations

The US Food and Drug Administration (FDA) recently issued a warning letter to TEI Biosciences, a unit of Integra LifeSciences, for releasing collagen-based products which failed bacterial endotoxin ...
RAPS

FDA addresses endotoxin levels in investigational cancer treatments

Oncology drug and biologics developers received new guidance on setting limits for endotoxins during the clinical trial process, in the form of a draft document from the US Food and Drug ...
Becker's Spine Review

FDA flags neurosurgery device shortage

Supply disruptions of neurosurgical patties, sponges and strip devices could affect patient care and neurosurgical procedures through the end of 2026, according to a May 6 letter by the FDA. The ...
CNBC

New White Paper Assists Medical Device Manufacturers with Changes to FDA Endotoxin Testing Guidelines

AGAWAM, Mass., Oct. 24, 2012 /PRNewswire/ -- A new white paper is available to assist medical device manufacturers with understanding recent changes to the U.S. Food and Drug Administration's (FDA) ...
FierceBiotech

Integra gets FDA warning letter after recalling 5 years' worth of devices made at Boston facility

Despite taking the dramatic step earlier this year of voluntarily recalling a broad swath of its regenerative tissue technologies and pausing further production at its Boston-based manufacturing ...
Dallas Observer

FDA Really Wants Dallas’ NuVision Pharmacy to Quit Making Drugs Contaminated by Endotoxins

If you more than glance at the website for NuVision Pharmacy, you might start having second thoughts about having the Dallas-based company compound your pharmaceuticals. Why, you might wonder by ...