AssurX Blog
Straight talk for regulated industries.
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 coverage, tasty bean soup in the Senate cafeteria, and the best pa [...]
Should FDA Get Tougher on IRBs?
Patrick Stone, President, TradeStoneQA The FDA says IRBs (Investigational Review Boards) are not required to collect a statement of investigator assurance from studies they preside o [...]
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 software, was developed from the perspective that product testing alon [...]
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's what the FDA requires from the medical device community starti [...]
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), the Center for Drug Evaluation and Research (CDER), and the C [...]
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 and Research (CBER) offers some helpful detail for device firms [...]
