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FDA Coronavirus (COVID-19) Update for April 1st, 2020

 

U.S. Food and Drug Administration - FDASilver Spring, MD – Last Wednesday, April 1st, 2020, the U.S. Food and Drug Administration (FDA) announced the following actions taken in its ongoing response effort to the Coronavirus (COVID-19) pandemic.

FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data Now Available: In response to the Coronavirus (COVID-19) pandemic, the FDA—in collaboration with the U.S. Centers for Disease Control and Prevention (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 United States.

Coronavirus

Coronavirus

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 issued a Constituent Update regarding guidance it released today to provide temporary flexibility to chain restaurants and similar retail food establishments currently required to provide nutrition information, including calories, on menus and menu boards.

The FDA is continuing to issue warning letters to companies for selling fraudulent Coronavirus (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. The agency will continue to pursue those that place public health at risk.

Diagnostics update to date: During the Coronavirus (COVID-19) pandemic, 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 31st FDA issued an EUA that authorizes eligible molecular-based laboratory developed tests, or LDTs, that are developed and used by a single CLIA high complexity laboratory. 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 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance. The U.S. Food and Drug Administration (FDA) also continues to keep its COVID-19 Diagnostics FAQ up to date.

Additional Resources:


Consumer Inquiries: 888.INFO.FDA

About the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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