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FDA News Release

Coronavirus (COVID-19) Update: December 30, 2020

For Immediate Release:

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

  • Today, the FDA published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. Furthermore, a new COVID-19 Communication Toolkits webpage provides links to all FDA toolkits on COVID-19 topics to help everyone communicate accurate and timely information to patients, the public, and health care professionals.
  • In a new FDA Voices entitled, 2020 at FDA: A Year of Unparalleled Contributions to Public Health, FDA Commissioner Stephen M. Hahn, M.D., highlights a sampling of the FDA’s achievements, many COVID-19-related, from this past year.
  • The agency has published online a new infographic, COVID-19 Tests and Collection Kits Authorized by the FDA in 2020, that provides a visualization of the wide variety of tests authorized.
  • Warning letters for unapproved and misbranded products related to COVID-19 were issued by the FDA to Sparrow & Health Performance LLC and Riverstone LLC
  • On Dec. 29, the FDA approved two abbreviated new drug applications (ANDAs), or generics, for heparin sodium injection. The agency continues to work to help patients suffering from COVID-19 by reviewing and approving generic medicines, such as anti-coagulants, used in the prevention and treatment of blood clotting.
  • Testing updates:
    • As of Dec. 28, 309 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 235 molecular tests and sample collection devices, 63 antibody tests, and 11 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, one antigen prescription at-home test, and one over-the-counter (OTC) at-home antigen test.

The 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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Jane Hubbard

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