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Training Management Best Practices for Emerging Life Science Companies
No matter how good your written policies are, or how clean a facility you operate, or how successful you are in the mark [...]
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 stage [...]
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 [...]
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 [...]
