Pearls of Wisdom
FDA plans to strength post marketing surveillance for medical devices through unique device identification systems
FDA plans to increase post market medical device surveillance even further though the implementation of four adjustments to the current program. The FDA report entitled, "Strengthening our National System for Medical Device Post Market Surveillance" lists the...
IMDMC is hosting annual conference Wednesday October 17, 2012- Save the date
The IMDMC 2012 annual conference will be held on Wednesday October 17, 2012 at the Montage Meeting Facility in Indianapolis, Indiana. Come prepared for a full day of events. The conference features FDA’s Steve Silverman, Director, Office of Compliance, and CDRH. Pearl...
EC GMP modifications could impact CMOs
The European Commission Directorate-General for Health and Consumers issued three revisions last week that impact various aspects of drug quality and biologic active pharmaceutical ingredients. The modifications range from relatively minor such as changes in one word...
INpact presents Jon Speer’s discussion of Hoosier Cooler
Pearl staff will be attending the upcoming INpact meeting. Hope to see you there. When: September 21, 2012 from 11:30am-1:00pm Where: Bingham Greenebaum Doll LLP. 10 W. Market Street. Suite 2700. Indianapolis, IN. Cost: $20 for nonmembers, free for members INpact is...
App allows diabetics to test glucose levels straight from their iPhone
If you thought you were using your iPhone to its full potential, think again. A new device and App has debuted in Australia which allows diabetics to prick their finger on the go, and record results on their iPhone. The device attaches to the end of the iPhone, reads...