FDA Collaborative Efforts with External Stakeholders to address the COVID-19 Pandemic

FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response FDA has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent COVID-19 research questions about the use of diagnostics and medications during the pandemic, and risk factors for COVID-19-related complications in different patient populations. Learn more. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a public-private partnership led by the National Institutes of Health (NIH) and coordinated by the Foundation for the National Institutes of Health (FNIH) to develop a research strategy for prioritizing and speeding development of the most promising COVID-19 vaccines and treatments.  ACTIV brings together NIH with its sibling agencies in the Department of Health and Human Services, including the Biomedical Advanced Research and Development Authority (BARDA), Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA); other government agencies, including the Department of Defense (DOD) and Department of Veterans Affairs (VA); the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations and biopharmaceutical companies. Learn more.

CURE ID App Last December, FDA in collaboration with the NIH’s National Center for Advancing Translational Sciences (NCATS), launched a data-sharing app called CURE ID. The CURE ID platform is an internet-based repository that allows clinicians to report novel uses of existing drugs for difficult-to-treat infectious diseases through a website, a smartphone or other mobile device.    FDA and NIH along with the Critical Path Institute have made updates to the CURE ID crowd-sourcing app to make it easier for healthcare providers to share — via mobile device or website — their experiences treating COVID-19 patients who are unable to be enrolled in a clinical trial. CURE ID’s web-based repository lets providers share experiences with novel uses of existing drugs in treating difficult-to-treat infectious diseases. Healthcare providers worldwide are encouraged to share their COVID-19 treatment experiences via CURE ID. Learn more.

Partnering with the European Union and Global Regulators on COVID-19  The FDA and the EMA have been exchanging information on the rapidly evolving scientific landscape of products and clinical trials and, as possible, discussing the interpretation of data supporting regulatory decisions. Learn more. COVID-19 Educational Resources  FDA has assembled educational videos, podcasts, social media tool kits, consumer articles, and other resources to help inform various stakeholders about the COVID-19 pandemic.