- 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:
- On March 16, the FDA posted a new web page on FDA.gov, Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs. This resource is intended for schools, workplaces, communities and others looking to establish testing programs to screen people without symptoms and with no known or suspected exposure to COVID-19. The FDA also posted a new template for test developers to help facilitate submission of an emergency use authorization (EUA) request for certain COVID-19 tests for screening using a serial testing approach.
- On March 17, the FDA posted two templates for serology tests with recommendations on what to include in Emergency Use Authorization (EUA) requests or Pre-EUA submissions: Template for Test Developers of Serology Tests that Detect or Correlate to Neutralizing Antibodies (New) and Serology Template for Test Developers (Update). The FDA updated the Serology Template for Test Developers to add clarity throughout and provide recommendations regarding monitoring for and assessing the impact of new SARS-CoV-2 mutations and variants. These templates provide the FDA’s current recommendations concerning what data and information should be submitted to the FDA in support of an EUA request or Pre-EUA submission for SARS-CoV-2 antibody tests. The templates are intended to help test developers provide validation data and other information to the FDA, but alternative approaches can be used.
- On March 17, the FDA granted BioFire Diagnostics LLC marketing authorization for its BioFire Respiratory Panel 2.1 diagnostic test. The grant of this De Novo request marks an important step in the FDA’s response to the COVID-19 pandemic because it is the first SARS-CoV-2 diagnostic test that will be permitted to be marketed beyond the public health emergency. The BioFire Respiratory Panel 2.1 is a multi-analyte molecular test that simultaneously detects 22 different viruses and bacteria associated with respiratory tract infections, including SARS-CoV-2, from a single nasopharyngeal swab. It is for use only for people suspected of respiratory tract infections, including COVID-19.
- On March 17, the FDA approved an abbreviated new drug application for azithromycin tablets USP, 500 mg, which is indicated for specified mild to moderate infections caused by designated, susceptible bacteria. Side effects of azithromycin tablets include hypersensitivity, QT prolongation, diarrhea, nausea, abdominal pain and vomiting. We remain deeply committed to facilitating access to medical products that are experiencing increased demand.
- The FDA authorized revised fact sheets for health care providers to include additional information on susceptibility of SARS-CoV-2 variants to each monoclonal antibody (mAb) therapy that is available through an Emergency Use Authorization for COVID-19 treatment. The fact sheets contain details regarding specific variants and potential resistance that may make the authorized mAb therapies less effective.
- The revised fact sheets are for:
- In a March 18 FDA Voices entitled FDA’s Ongoing Use of Inspectional Tools for Ensuring Access to Safe, Quality Food and Medical Products During the COVID-19 Pandemic, FDA leaders explain that over the past year, the agency’s approach to foreign and domestic inspections for food and medical products has been both risk-based and deliberate. The COVID-19 pandemic required us to rework our business operations so that we could carry out our public health mission while protecting our workforce, and the workforces of those we regulate.
- Testing updates:
- As of today, 341 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 254 molecular tests and sample collection devices, 72 antibody and other immune response tests, and 15 antigen tests. There are 38 molecular authorizations that can be used with home-collected samples. There is one molecular prescription at-home test, two antigen prescription at-home test, one over-the-counter (OTC) at-home antigen test, and one OTC molecular test.