AssurX Blog
Straight talk for regulated industries.
Quality Takes Time, FDA’s CDER Reminds Drug Makers
Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in stages between the Fifth Century B.C. and the Sixteenth Century A.D. [...]
FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism
Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Center for Devices & Radiological Health) new proposed guidance development and goals for 2015 reminds [...]
FDA’s CDER Unveils Ambitious 2015 Wish List
The holidays came a little early for the folks at the Center for Drug Evaluation and Research (CDER). They just released their sometimes optimistic, but always enlightening guidance wi [...]
Are Energy and Utility Companies Ready for Risk Based Compliance?
Part 1: How the NERC Registered Entities are Preparing As we enter into the New Year, many NERC Registered Entities are focused on their game plan to prepare and implement the “ERO En [...]
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for Fiscal Year 2014
FDA FastStats: A Look Back at all FDA 483 Inspectional Observations for the Fiscal Year 2014 - In our last FDA FastStats series of the year, we look back at all FDA 483 Inspectional Ob [...]
FDA Update on UDI Implementation for Registered Medical Device Establishments
In case you missed it, the FDA issued this update on UDI yesterday: Having passed the first Unique Device Identification System compliance date of September 24, 2014 (for Class III dev [...]
