Quality Takes Time, FDA’s CDER Reminds Drug Makers
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Scholars stil [...]
21
01, 2015
8
01, 2015
FDA’s CDER Unveils Ambitious 2015 Wish List
The holidays came a little early for the folks at the Center for Drug Evaluation [...]
9
12, 2014
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 [...]
3
12, 2014
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality System Deficiencies
FDA FastStats: A Look Back at 2013 Medical Device Warning Letters with Quality S [...]
25
11, 2014
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations
FDA FastStats: A Look Back at 2013 Medical Device 483 Observations: As we approa [...]
24
11, 2014
FDA’s Local Offices Flex Regulatory Muscle
In our latest round-up, it was the District Offices turn to chime in on medical [...]
21
11, 2014
Are You Ready for 21st Century eMDR Submissions?
Jeff Mazik, Vice President, Life Science Solutions, AssurX If you have been pr [...]
15
10, 2014
FDA Warning Letter Analysis: CAPA, CAPA, and More CAPA!
After a flurry of activity, it's been relatively quiet of late on the FDA warnin [...]
24
09, 2014
FDA Proposals Take a Fresh Look at Some Stale Food Issues
That landmark Food Safety Modernization Act (FSMA) just keeps getting more and m [...]
13
08, 2014
FDA Guidance Advises Device Makers to Think About Home-Use
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Medical devic [...]
