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Life Sciences
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 [...]
FDA Works to Clarify Device Data Collection Priorities
A new FDA guidance issued by the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation [...]
