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

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 Founda

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 abo

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.

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.