Current FDA COVID-19 advice and actions
While the US climbs near 8m total reported COVID-19 infections since the onset of the pandemic, the US Food and Drug Administration (FDA) continues to put out online resources, guidance documents, and other helpful tools for researchers, pharma firms and other key players. Here are the latest developments from the FDA’s COVID-19 response.
Tissue analysis contract
FDA awarded a new research contract to the Stanford University School of Medicine to perform an in-depth analysis of tissue samples to learn more about how SARS-CoV-2—the virus that causes COVID-19—affects different systems in the body, and identify immune correlates. This regulatory science project could potentially help inform development and evaluation of medical countermeasures for COVID-19.
Collaborators on the research include:
- Public Health England (UK)
- Integrated Research Facility at the National Institutes of Health (NIH)
- California National Primate Research Center at UC Davis
- Erasmus University Medical Center
- Wisconsin National Primate Research Center (WNPRC)
- Harvard Medical School Center for Virology and Vaccine Research
- University of Pittsburgh Graduate School of Public Health
- University of Liverpool (UK)
- University of California San Francisco
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) (Mexico)
- Inflammation in COVID-19 – Exploration of Critical Aspects of Pathogenesis (ICECAP) consortium
- University Hospital Basel & Cantonal Hospital of Liestal, Switzerland
Drug development summary
The FDA recently updated the dashboard on the Coronavirus Treatment Acceleration Program (CTAP) online resource. The webpage serves to inform and update users about the program, which is designed to help promote and accelerate development of COVID-19 therapies.
As of September 30, 2020, more than 550 drug development programs were in the planning stages, according to the agency. Further, more than 350 trials had been reviewed by the FDA at that point, and five COVID-19 treatments were by then currently authorized for emergency use.
Vaccine actions
The agency issued a guidance document with recommendations for sponsors pursuing vaccine solutions to guard against COVID-19 infection. The resource includes scientific data and information that would support issuance of an emergency use authorization (EUA) for investigational vaccines intended to prevent COVID-19.
Additionally, the FDA launched a new website designed to keep vaccine developers, researchers and other stakeholders apprised of developments. The agency plans to enhance the online resource with additional information as appropriate when it becomes available.
Fradulent COVID-19 products
The agency continues to field complaints about, and issue warnings to, companies offering products purported to detect, prevent, treat or cure COVID-19 infections. Currently there are no FDA-approved COVID-19 products on the market.
The latest companies to receive such a slap on the wrist:
- Griffo Botanicals, a company offering herbal tincture products
- Prairie Dawn Herbs, a manufacturer promoting herbal treatments
