Past Events

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.
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 de
New COVID-19 Diagnostics Evidence Accelerator Applies Real-World Data to Answer Urgent Questions on SARS-CoV-2 Testing
Today, the Reagan-Udall Foundation for the FDA, in collaboration with Friends of Cancer Research, announced the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder, collaborative project to leverage real-world d
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.
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.
A New Trend in Drug Development: Leveraging Data from Expanded Access - Cancer Therapy Advisor
A manuscript detailing this study is under revision and awaiting acceptance by the British Journal of Clinical Pharmacology.
WHEN YOU DON’T QUALIFY FOR A CLINICAL TRIAL: EXPANDED ACCESS MIGHT HELP - Triage Cancer
When dealing with a cancer diagnosis, often times the best form of treatment can be offered through a clinical trial.
Real-World Data Partnership On COVID-19: US FDA Drawn To Consistency, Diversity of Aetion's Datasets - Pinksheet
FDA's Amy Abernethy tells the Pink Sheet that initial priorities are likely to include studying COVID-19 natural history and how patients are faring under various medication regimens.
Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response
Today, we are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S.
FDA Teams Up With Data Company Aetion to Study Virus Progression - Bloomberg Law
The FDA said Tuesday it’s pairing up with the data company Aetion to research Covid-19 complications and what types of medicines virus patients are taking, which could help researchers learn more about which treatments are