Incomplete and inconsistent capture of information about race and ethnicity in real-world data (RWD) limits a full understanding of the distribution, safety, and effectiveness of FDA-regulated products, which impacts the health of the public.
The Reagan-Udall Foundation for the FDA, in partnership with the U.S. Food and Drug Administration (FDA), hosted a virtual public meeting on March 8-9, to explore the evolving context surrounding fatal overdoses.
Join us to observe the in-person public meeting of the Food Independent Expert Panel on September 29 & 30. We'll be gathering input from invited stakeholders including consumer, research/academia, government, and industry representatives. You can join in-person (limited space available) or virtually (audio-only feed). During registration you can choose to attend the full meeting virtually or in-person. Note: if attending in person, you must register for each day separately that you want to attend.
Eric Young of TriNetX will take us through the characterization of breakthrough infections for vaccinated individuals, including children, who received both outpatient and inpatient treatment. Sonia Hernandez-Diaz, Harvard T.H. Chan School of Public Health, will share her experience with “Target trial emulation to evaluate COVID-19 vaccination during pregnancy” using RWD from Israel. Carla Rodriguez-Watson will preview of the Real-World Accelerator to evolve the standard of Care and Engagement (RACE) for communities of color.
Professor Mara Aspinall of the Diagnostic Commons housed at Arizona State University will join us to reflect on the past, present and future of diagnostic tests. Matthew Gee of Siemens will take a look at lessons learned from using real-world data in regulatory submissions for COVID diagnostics tests. Carla Rodriguez-Watson will provide a preview of the Real-World Accelerator to evolve the standard of Care and Engagement (RACE) for communities of color.
On October 20, 2022, we highlighted the accomplishments and shared learnings from more than 200 meetings, and 275 expert presentations, including how best to leverage real-world data and improve data interoperability to address current and future health challenges.
Join us Thursday, July 21 at 3 pm ET for the July Therapeutics & Vaccines lab Meeting. We’ll be hearing from Elizabeth Eldridge of Health Catalyst. Liz will be describing the new research project they are taking on at the request of the Evidence Accelerator, looking at the use of dexamethasone in COVID-19 patients.
In addition, we will be receiving an update on the Real-World Evidence Online Primer.
Join us Thursday, July 21 at noon ET to hear from Dr. Keith Campbell of FDA's Center for Devices and Radiological Health. He'll be speaking about Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD), a public-private initiative to develop and launch collaborative policies and business models designed to overcome barriers to the interoperability of laboratory data. Dr. Campbell will be providing an update about SHIELD from FDA’s perspective.
