From our Annual Public Meeting to topic-specific convenings, the Reagan-Udall Foundation for the FDA brings stakeholders together on matters critical to regulatory science and practice. These events, often hosted at the request of FDA leadership, provide space for expert analysis and candid discussion on FDA’s priority issues. See below for upcoming events.

Past Events

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
FDA, partnering with New York health tech firm, seeks to collect ‘real-world’ data on Covid-19 - STAT
The Food and Drug Administration said Tuesday that it will launch a new research project focused on real-world evidence — data collected by insurance companies, in electronic health records, and in other places in medicine