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Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
Big Pharma Goes Big for Big Data
When it comes to data, big pharma knows what big pharma likes, according to a new survey of giant pharmaceutical compani [...]
Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation
Just when we'd all decided Washington lawmakers couldn't do much more than enjoy their own excellent health insurance co [...]
Should FDA Get Tougher on IRBs?
Patrick Stone, President, TradeStoneQA The FDA says IRBs (Investigational Review Boards) are not required to collect a [...]
Avoid Common Medical Device Software Development Life Cycle, IEC 62304 Pitfalls
IEC 62304, the international standard that defines software development lifecycle requirements for medical device softwa [...]
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR
FDA FastStats: CDRH Shows Significant Growth in Electronic Submissions; Deadline Looming for eMDR - No more paper. That' [...]
FDA’s Action Plan Demands Some Industry Action, Too
“The following Pharmaceuticals FY 2015 Action Plan (the Action Plan), developed by the Office of Regulatory Affairs (ORA [...]
