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Coronavirus (COVID-19) Update: January 15, 2021

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 issued and immediately implemented a new guidance entitled, “Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency.” This guidance assists prospective applicants of abbreviated new drug applications (ANDAs) on ensuring participants are protected when resuming or initiating bioequivalence studies conducted to support the approval of an ANDA that has been disrupted during the COVID-19 public health emergency. 
  • On January 14, the FDA issued and immediately implemented a new guidance entitled, “Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.” Hypercoagubility has been observed in patients with COVID-19. The guidance is intended to foster the continued availability of safe and effective medical devices while being flexible regarding certain modifications made to coagulation systems for measurement of whole blood viscoelastic properties to include use in hospital patient healthcare settings in response to the COVID-19 public health emergency.
  • On January 13, the FDA issued a temporary guidance entitled, “COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity.” This guidance describes methods that applicants should use to ensure the potency of monoclonal antibodies and other therapeutic proteins proposed for use as anti-infective agents for COVID-19. The FDA issued this guidance to help development of monoclonal antibodies and other therapeutic proteins for use as COVID-19 therapeutics.
  • Testing updates:
    • As of January 15, 317 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 236 molecular tests and sample collection devices, 68 antibody tests, and 13 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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