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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 Healt [...]
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 [...]
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 [...]
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 [...]
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 [...]
Got Safe Beef? New Report Suggests the US Doesn’t
FSMA: Got Safe Beef? New Report Suggests the US Doesn't: The next time you want a cheeseburger, you might consider hoppi [...]
