AssurX Blog
Straight talk for regulated industries.
FDA’s Shuren Works to Assure Device Industry Innovators
Calling it something of a “culture change” at the Center for Devices and Radiological Health (CDRH), Director Jeffrey Shuren said his team is working hard to find ways to speed approva [...]
FDA Moves UDI Initiative Further Down the Production Line
We, and others, like to take the FDA to task for missing deadlines or behaving in ways that are sometimes difficult to fathom. But it’s only fair to give equal space to something when [...]
Large Utilities Power Up with AssurX Enterprise GRC Solution
Increasingly complicated, and disparate, regulatory requirements and a demand for improved compliance management were driving forces for two major utility companies to find a stronger [...]
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 companies that included AstraZeneca, Merck, Pfizer and Boehringer Ingel [...]
Congress Crawls Out of 20th Century to Push Bi-partisan ‘Cures’ Legislation
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Just when we'd all decided Washington lawmakers couldn't do much more than enjoy their own excellent health insurance [...]
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 [...]
