The following are some of the U.S. FDA’s actions taken, as of April 2, in its ongoing response effort to the COVID-19 pandemic:
-
FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available: The FDA—in collaboration with the CDC, the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) and the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information (NCBI)—developed quality-controlled, reference sequence data for the SARS-CoV-2 reference strain for the U.S. Availability of traceable and quality-controlled data will help test developers and vaccine developers:
- Expedite development of medical countermeasures.
- Identify new or more stable targets for future tests.
- Enable in silico confirmation of targets.
- Support development of synthetic reference material.
- Enable viral population/quasi species analysis.
- The FDA is continuing to issue warning letters to companies for selling fraudulent COVID-19 products, as part of the agency's effort to protect consumers. FDA and FTC issued a warning letter to Neuro XPF, which sells cannabidiol (CBD) products in the U.S. with the misleading claim these products can mitigate, prevent, treat, diagnose, or cure COVID-19.
- Diagnostics update to date: The FDA has worked with more than 220 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus. To date, 23 emergency use authorizations have been issued for diagnostic tests. On March 31stFDA issued an EUA that authorizes eligible molecular-based lab developed tests, or LDTs, that are developed and used by a single CLIA high complexity lab. Under this EUA, FDA has authorized Yale New Haven Hospital's SARS-CoV-2 PCR test. Additionally, the FDA has been notified that more than 110 labs have begun testing under the policies set forth.