The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
- The FDA issued information on the use of serological (antibody) tests to help identify people who may have been exposed to the SARS-CoV-2 virus or have recovered from the COVID-19 infection. This information includes:
- Important Information on the Use of Serological (Antibody) Tests for COVID-19 – Letter to Health Care Providers;
- FDA Fact Sheet – Serological Testing for Antibodies to SARS-CoV-2 Infection; and
- New Serology/Antibody Test FAQs in the FAQs on Diagnostic Testing for SARS-CoV-2.
- The FDA issued a face mask emergency use authorization (EUA) in response to concerns relating to insufficient supply and availability of face masks for use by members of the general public, including health care personnel in healthcare settings as personal protective equipment (PPE), to cover their noses and mouths, in accordance with Centers for Disease Control and Prevention (CDC) recommendations, to prevent the spread of the SARS-CoV-2 virus during the pandemic. Manufacturers of face masks that are used as described in the EUA and meet the requirements in the EUA, do not need to take any action, other than complying with the Conditions of Authorization in the EUA, to be authorized under this EUA.
- Today, the FDA issued a guidance explaining a temporary policy regarding state-licensed pharmacies and federal facilities, that are not outsourcing facilities, compounding certain human drugs for hospitalized patients during the COVID-19 public health emergency. This guidance explains the agency’s policy to help address reported issues with accessing certain FDA-approved drugs used for hospitalized patients with COVID-19. As a temporary measure, with regard to certain drugs, under the circumstances outlined in the guidance, FDA does not intend to take action against state-licensed pharmacies and federal facilities for compounding a drug that is essentially a copy of a commercially available drug, or for providing a drug to a hospital without obtaining a patient-specific prescription. When a hospital is unable to access FDA-approved drug products and is considering the use of compounded drugs for hospitalized patients, outsourcing facilities may be able to offer a supply of compounded drugs that are subject to more robust quality standards than are drugs produced by State-licensed pharmacies or Federal facilities that are not required to comply with CGMP requirements.
- A new FDA Voices was issued, The Path Forward: Coronavirus Treatment Acceleration Program, describing a new program that aims to move new treatments to patients as soon as possible, while at the same time finding out whether they are helpful or harmful. So far, 72 clinical trials of potential therapies for COVID-19 are underway with FDA oversight. Both the pharmaceutical industry and academic researchers have submitted many innovative and well-designed studies for prevention and treatment of COVID-19. The FDA has streamlined its review and advice process to get studies started as quickly as possible.
- Diagnostics update to date:
- During the COVID-19 pandemic, the FDA has worked with more than 340 test developers who have said they will be submitting emergency use authorization (EUA) requests to FDA for tests that detect the virus.
- To date, the FDA has issued 41 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 16 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
- The FDA has been notified that more than 210 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 FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.
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