Michael Causey

Editor and publisher

James Michael Causey’s been a journalist since he started his own neighborhood newspaper in the 1970s. In addition to quizzing FDA officials for the past 10+ years, he’s also interviewed political satirist Art Buchwald, FCC Chairman Reed Hundt, SEC Chairwoman Mary Schapiro, and is the past president of the Washington Independent Writers. Causey is the editor and publisher of eDataIntegrityReport.com and is a contributing writer on the AssurXblog.

Tue, 04/11/2017 - 12:02
FDA Budget Could Hike User Fees, Overseas Inspections Also, expect more frequent and stricter enforcement
Tue, 03/13/2012 - 12:49
Budget-conscious firms that do business in China and elsewhere outside the United States may not like what they find in the Food and Drug Administration’s (FDA) request in the Budget of the United States Government, Fiscal Year 2013. While it is one…
CDRH 2012 Strategic Priorities Emphasize QA, Life Cycle Management Improving premarket programs heads the list
Mon, 03/05/2012 - 11:50
Deciphering the Food and Drug Administration (FDA) is a bit like trying to understand what the old USSR was up to during the days of the Cold War. In those days, it was called Kremlinology, or the study of a complex, secretive organization. We need…
FDA Offers Salty Recipe for Increased Food Regulation To salt or not to salt? That is the question. Well, one of them.
Fri, 01/06/2012 - 12:11
It’s actually bigger than a battle over a popular condiment, according to some folks who oppose what they say is the Food and Drug Administration (FDA) overplaying its regulatory hand. We’re not going to settle this controversy here, but some…
FDA Reorganization Signals More Inspections for Drug, Device Firms Moving target of enforcement priorities will affect midsize device makers
Fri, 10/07/2011 - 11:25
Under pressure from all sides, the beleaguered Food and Drug Administration (FDA) keeps announcing new reorganization initiatives, name changes, and all sorts of stuff that would be funny if it was scripted by the same team handling Steve Carell…
Independent Study Finds FDA 510(k) Review Process Has Slowed Be prepared to defend what you submit, warns analyst
Tue, 07/05/2011 - 14:52
Well, this is getting interesting. For the past several months, we’ve had relatively partisan folks on each side of the medical device industry vs. the Food and Drug Administration (FDA) debate saying either the 510(k) premarket notification  …