Blog Posts with Tag: Ex-US

The Essentials of Essential Requirements
The challenging part is trying to figure out which strategy of meeting the essential requirements works best for the manufacturer.
Wednesday, December 08, 2010
Life on the A List
Requirements for List A products are similar to those for a PMA
Tuesday, November 09, 2010
Mind Your PQ's (and IQ's and OQ's)
These terms aren't defined in regulation, so what exactly do they mean?
Tuesday, October 05, 2010
Hearing Global Harmonization
Getting a handle on national and regional requirements can be time-consuming
Tuesday, September 28, 2010

Recent Blogs

BNP tests Reducing the time to treatment for patients with heart failure
HPV Tests Helping to allay women's fears about a life-threatening disease
Molecular Diagnostics for Influenza Making point-of-care diagnosis possible
Rapid Influenza Detection Tests Helping doctors decide who needs antivirals, and who needs chicken soup