FDA Moves UDI Initiative Further Down the Production Line
We, and others, like to take the FDA to task for missing deadlines or behaving i [...]
10
06, 2015
4
06, 2015
Large Utilities Power Up with AssurX Enterprise GRC Solution
Increasingly complicated, and disparate, regulatory requirements and a demand fo [...]
28
05, 2015
Big Pharma Goes Big for Big Data
When it comes to data, big pharma knows what big pharma likes, according to a ne [...]
20
05, 2015
Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Just when we' [...]
11
05, 2015
Should FDA Get Tougher on IRBs?
Patrick Stone, President, TradeStoneQA The FDA says IRBs (Investigational Revi [...]
30
04, 2015
Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls
Russ King, Managing Partner, Methodsense IEC 62304, the international standard [...]
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 [...]
