This week's FDA COVID-19 news

By Jenni Spinner contact

- Last updated on GMT

(Isabela Maia Studio/iStock via Getty Images Plus)
(Isabela Maia Studio/iStock via Getty Images Plus)

Related tags: Fda, COVID-19, Coronavirus, Testing, Regulation

The agency continues to provide resources for the life-sciences industry, approve tests, and take action against companies offering false treatments

As the number of COVID-19 cases continues to increase globally, the US Food and Drug Administration (FDA) maintains a watchful eye on the industry, offering guidance and issuing approvals for development of tests and treatments.

Drug shortages update

The FDA updated its COVID-19 Drug Shortages Response web page​ to provide information regarding in-use time for certain drugs during the COVID-19 public health emergency. “In-use time” is the maximum amount of time that can be allowed to elapse between penetration of a container-closure system containing a sterile drug product, or after a lyophilized drug product has been reconstituted, and before patient administration.

The information, intended for health care facilities and providers, on in-use time is intended to minimize the likelihood of physicochemical degradation or microbial proliferation during use in situations where a provider is considering use beyond the labeled in-use time for the specified products.

Serology tests

The FDA issued its first two authorizations for COVID-19 serology tests. These tests display any antibodies present in the tested individual’s blood.

Both tests—the ADVIA Centaur COV2G and Atellica IM COV2G—are issued by Siemens. Both of the tests are deemed “semi-quantitative,” meaning they share an estimated quantity of antibodies, rather than a precise measurement.

Being able to measure a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean​,” said Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “There are still many unknowns about what the presence of SARS-CoV-2 antibodies may tell us about potential immunity, but today’s authorizations give us additional tools to evaluate those antibodies as we continue to research and study this viru​s.”

To date, the FDA has authorized 203 tests under emergency use authorizations (EUAs). These include 166 molecular tests, 35 antibody tests, and 2 antigen tests.

Fraudulent COVID-19 products

The agency continues to take action against companies who unscrupulously sell products claiming to prevent, treat or cure the virus. To date, it has not approved any such products for sale in the US.

The latest companies to receive warning letters include:

  • Two companies, New Life International and Fishman Chemical of North Carolina, were cited for distributing chloroquine phosphate products (intended to treat disease in aquarium fish) for human consumption.
  • Vapore LLC, selling a product called Mypurmist
  • MMSTabs.com, for selling various products claimed to mitigate, prevent, treat, diagnose, or cure COVID-19

Related topics: Markets & Regulations, Regulatory affairs

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