Warning Letter Roundup & Recap – October 13, 2015
This article was originally published in The Gray Sheet
An FDA investigator observed two different products with the same lot number at a manufacturer of cannulas and trocars; employees at Lusys Labs – a maker of in vitro diagnostic kits – handled and packaged coated membranes with bare hands; procedures at software-maker Merge Healthcare allowed for devices that hadn't fully completed design validation to be shipped to end users for clinical use on patients; and more. Six device warning letters were listed by FDA this week.
You may also be interested in...
The European pharmaceutical industry federation, EFPIA, says its member companies are not looking for shortcuts to develop and validate digital biomarkers, but want help from regulators to create the right evidence.
Low- and middle-income countries need to have the know-how, capability and capacity to produce mRNA vaccines, from concept, design and testing through to manufacturing and registration, a conference heard this week.
The number of conditional marketing authorization non-renewals could increase.