Coverage

HAHN PLEDGES TO EVALUATE FUTURE OF DIAGNOSTICS REGULATION - POLITICO Prescription Pulse
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…
Read More
Pandemic pushes FDA to 'accelerate' real-world evidence efforts, Hahn says - MedTech Dive
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…
Read More
FDA joins Reagan-Udall, Friends of Cancer Research to form COVID-19 Diagnostics Evidence Accelerator - The Cancer Letter
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…
Read More
Accelerating the fight against COVID-19 with real-world data on tests - BioCentury
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…
Read More
To expedite progress against COVID-19, a public-private “accelerator” taps into real-world data - The Cancer Letter
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.
Read More
,
Real-World Evidence On COVID-19: US FDA Approaching With 'Sense Of Urgency'
The COVID-19 pandemic is forcing the US Food and Drug Administration to step outside its comfort zone when it comes to using real-world evidence to inform rapid regulatory decision-making and clinical trial design. This experience could have a…
Read More
FDA joins new, public-private COVID-19 diagnostic research accelerator effort - FierceBiotech
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…
Read More
New accelerator to boost real-world COVID-19 diagnostics - Regulatory Focus
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…
Read More
US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines - Pinksheet
Principal Deputy Commissioner Amy Abernethy suggests FDA may clear a COVID-19 vaccine on smaller than usual clinical datasets and rely on real-world data to fill in the gaps. Abernethy said a new public-private partnership is starting to explore how it…
Read More
The pivotal role of real-world data in a pandemic - Biocentury
Real-world data is taking on a critical role in the age of COVID-19 drug development, where hasty authorizations are being made on limited datasets and natural history data is being collected in real time. Teams across the industry have stepped up to…
Read More