Traditionally, the healthcare industry has moved slowly when embracing new technology innovations.

However, over the past few months, it has been forced to rapidly advance to confront the challenges posed by COVID-19. One area that has received increased attention is real-world data (RWD), specifically, the ways in which RWD can be used in clinical research to quickly reveal insights about treatments, outcomes, and risk factors for COVID-19.

The FDA will participate in the Covid-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research.

Read more

At a Medical Device Innovation Consortium fireside chat Thursday, FDA Commissioner Stephen Hahn said the agency will take a fresh look at how it regulates diagnostics and digital technologies after the coronavirus pandemic.

The FDA will be working to provide industry what data it believes is needed “to make that first assessment of patient safety, according to Hahn.

Read more

FDA is upping efforts to incorporate real-world data in evaluation of COVID-19 diagnostics and antibody tests, announcing Thursday participation in a partnership exploring how to use that data to improve testing quality, better inform population testing strategies and help understand how widespread the virus is.

Read more

FDA is participating in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics.  The accelerator is organized by the Reagan-Udall Foundation for FDA in collaboration with Friends of Cancer Research.