Coverage

The U. S. Food and Drug Administration has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science…
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…
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…
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…
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…
Almost every aspect of the fight against COVID-19 depends on the ability to determine whether an individual is or has been infected with SARS-CoV-2, but more than six months into the pandemic there is still uncertainty about the accuracy of widely used…
This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.
The FDA has joined a public-private diagnostic research project with the goal of bringing more real-world data to bear against the novel coronavirus, and gauging the accuracy of different kinds of tests. Formed by the Reagan-Udall Foundation and…
A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with…