For immediate release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response efforts to the COVID-19 pandemic:

  • Today, the FDA issues consumer updates, Tips on using good nutrition and the latest nutrition information labels during coronavirus pandemics. This update uses the Nutrition Facts label to give you helpful tips to find out more about your food or what you are buying online or in store. Temporary disruption of the food supply chain Or you are buying canned or packaged food instead of fresh food.
  • US Department of Justice with support from the FDA’s Department of Criminal Investigation and chief prosecutor Announced Today, the Utah federal court has entered an injunction suspending the sale of various silver products, which are being promoted as COVID-19 treatments.
    It’s a sequel.

    • “The FDA will continue to help ensure that people who make more than public health gains during the COVID-19 pandemic are stopped.” Judy McMikin, Pharma D, FDA Associate Commissioner,. “We are working with the Department of Justice to provide and distribute products with unproven claims to prevent or treat COVID-19, making it suitable for those who endanger the health of Americans. We are committed to taking action. “
  • FDA Accelerated approval granted A new dosing regimen for cancer treatment so that certain cancer patients can continue treatment with fewer interviews. Specifically, the new dosing regimen will reduce the frequency of patients visiting cancer centers while receiving the treatment they need. This application was approved more than 5 months before the FDA target date.
  • Yesterday, the FDA Emergency authorization (EUA) for SARS-CoV-2 antibody testing National Institutes of Health (NIH) National Cancer Institute (NCI) or an independent validation study conducted by another government agency designated by the FDA to meet the criteria listed in the FDA’s scope Approval confirmed by. Under this serological “umbrella” EUA, approved devices show an adaptive immune response to SARS-CoV-2, which indicates recent or previous infection by detecting antibodies (IgG, or IgG and IgM). It is intended for use as an aid in identifying an individual. Total), SARS-CoV-2 in human plasma and / or serum as specified in the approved instructions for each device. Emergency use of approved devices is limited to accredited laboratories certified under the 1988 Laboratory Improvement and Improvement Clause to perform tests of moderate or high complexity. Approved devices will be added to Appendix A and posted on the FDA website.
  • FDA recently posted Ventilator FAQIncludes ventilator enforcement policies and ventilator-related questions and answers regarding ventilators. It has been added to the “umbrella” EUA and added to the existing FAQ on public availability (open sourcing) of ventilator software and design.
  • FDA also recently posted COVID-19 EUA FAQ for medical devices during a pandemicHow to submit a new EUA request, what happens to your authorized devices after a public health emergency ends, and so on.
  • Update diagnostics to date:
    It’s a sequel.

    • During the COVID-19 outbreak, FDA says it will work with more than 380 test developers to submit an Emergency Use Authorization (EUA) request to FDA for testing to detect viruses.
    • To date, the FDA has issued 50 individuals Emergency use permit For test kit manufacturers and laboratories. In addition, 23 approved tests have been added to the EUA certificate of Complicated Molecular Based Lab Development Testing (LDT).
    • The FDA was notified during public health emergency guidance that more than 235 laboratories have begun testing under the policies set forth in COVID-19 Policy for Diagnostic Testing of Coronavirus Disease-2019.
    • The FDA also COVID-19 diagnostic FAQ latest.

An agency within the U.S. Department of Health and Human Services, the FDA guarantees the safety, effectiveness, and safety of human and veterinary medicines, vaccines, and other human-used biological products, medical devices. Protects public health. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit e-radiation, and regulation of tobacco products.

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