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

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
A New, Better Normal in Health Care? - National Review
The COVID-19 crisis has fast-tracked long-contemplated, patient-centric changes in medicine.
BioCentury This Week: Special Edition - Getting Real about COVID-19 Data
Amy Abernethy, FDA’s principal deputy commissioner and acting CIO, and Mark McClellan, director of the Duke-Margolis Center for Health Policy at Duke University, described in podcast interviews with BioCentury’s Washington
Health, Defense Agencies Should Cooperate to Beat COVID-19 - RealClearHealth
The U.S. has been trying to contain COVID-19 through testing and social distancing. Now it’s time to kill it.