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Clear, actionable intelligence for regulated industries.
Expert perspectives that simplify complexity and support stronger quality and compliance outcomes.
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 Sh [...]
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 f [...]
Large Utilities Power Up with AssurX Enterprise GRC Solution
Increasingly complicated, and disparate, regulatory requirements and a demand for improved compliance management were dr [...]
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 [...]
