COVID-19: Report Finds Staffing, IT Issues Posed Challenges To EUA Process
Executive Summary
The agency asked consultants Booz Allen Hamilton to evaluate its handling of diagnostic EUAs as a way to prepare for potential future pandemics.
You may also be interested in...
Abbott Preps For Potential VALID Act For Diagnostics While Pushing For More Clarity
Abbott says it’s preparing for the possible passage of legislation that would, among other things, create a new regulatory framework for diagnostic tests. But the manufacturer is also asking for more specificity around the bill’s quality requirements.
New FDA Office Aims To Improve IT Interactions With Sponsors
The US agency’s new Office of Digital Transformation will aggregate a number of IT operations under one office to streamline the agency’s work, including its interactions with device sponsors.
‘Core Pillars’ Of Safety And Innovation Take Center Stage In FDA Reports
The US FDA has issued a pair of reports focused on device safety and innovation. The reports describe recent steps the agency has taken to improve in the two areas, and what it plans to do next.