We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Following the outbreak of infections related to a deadly superbug, the FDA has provided new guidelines to help healthcare facilities ensure their duodenoscopes are cleaned adequately. Read More
Belgium-based Euromi was slapped with a far-ranging FDA warning letter that chides the company for not properly handling complaints, including instances in which cannula tips from a liposuction system broke and became lodged in patients. Read More
The FDA has cited data integrity as one of the most important GMP issues because it lies at the crux of all GMP systems. John Avellanet, managing director and principal at Cerulean Associates, sat down with FDAnews to talk about how companies should be handling their data.Read More
The U.S. FDA has extended until Oct. 24 the deadline to submit required labeling and data to the Global Unique Device Identification Database following the discovery of a security vulnerability. Read More
A bipartisan group of lawmakers is calling on the head of the U.S. Government Accountability Office to investigate why power morcellators remained on the market for more than two decades before being slapped with a black box warning last year.
Read More
FDA handed devicemaker Synovis a Form 483 for not initiating corrective and preventive actions for nonconformities to its Terminally Sterilized Vascu-Guard patch. Read More
Improving inspection activities and concentrating on postmarket surveillance to enhance patient safety are two areas where Brazil’s Agência Nacional de Vigilância Sanitária made strides in 2014, according to a new report. Read More
To comply with FDA’s combination product good manufacturing practices, both devicemakers and drugmakers should first look at their systems and conduct a gap analysis using both the quality system regulation and drug cGMPs. Read More
Olympus is facing tough questions from the FDA following inspections conducted in April and May of four facilities that manufacture duodenoscopes. The company — along with Pentax and Fujifilm — is facing scrutiny after improper cleaning of its complex endoscopes was linked to patients becoming sick or dying. Read More