Should FDA Get Tougher on IRBs?
Patrick Stone, President, TradeStoneQA The FDA says IRBs (Investigational Revi [...]
11
05, 2015
28
04, 2015
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline [...]
23
04, 2015
FDA’s Action Plan Demands Some Industry Action, Too
“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed [...]
20
04, 2015
FDA Works to Clarify Device Data Collection Priorities
Michael Causey, Editor & Publisher, eDataIntegrityReport.com A new FDA gui [...]
9
04, 2015
FDA Plays Catch Up In Brave New World of Electronic Consent
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Informed cons [...]
11
03, 2015
Brookings Looks to Advance Medical Device Postmarket Surveillance System
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Patients and [...]
2
03, 2015
FDA Gives MDDS World a Big Break
Sometimes it’s nice to be told what the FDA isn’t going to do. The agency issued [...]
21
01, 2015
Quality Takes Time, FDA’s CDER Reminds Drug Makers
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Scholars stil [...]
14
01, 2015
FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism
Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Cen [...]
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 [...]
