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The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
- On Nov. 22, the FDA authorized three over-the-counter (OTC) COVID-19 antigen diagnostic tests for people age 14 years or older with a self-collected nasal swab sample or people age 2 years or older when an adult collects the nasal swab sample.
- The InBios SCoV-2 Ag Detect Rapid Self-Test delivers results in about 20 minutes. The test can be used as:
- A single test for people with COVID-19 symptoms within the first five days of symptom onset.
- A serial test for people without symptoms, meaning the test is done two times over three days.
- The Access Bio CareStart COVID-19 Antigen Home Test gives results in 10 minutes. The test can be used:
- As a single test for people with COVID-19 symptoms.
- As a serial test for people without COVID-19 symptoms, meaning the test must be done twice over three days.
The FDA reissued the EUA to authorize use of CareStart COVID-19 Antigen Home Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without symptoms.
The FDA reissued the EUA to authorize use of the BD Veritor At-Home COVID-19 Test as a single test without a prescription for people with COVID-19 symptoms. The test was already authorized for use as a serial test without a prescription by people with or without COVID-19 symptoms.
- On Nov. 18, the FDA approved an abbreviated new drug application for vancomycin hydrochloride for injection, indicated to treat serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. The side effects of vancomycin hydrochloride for injection include diarrhea, hypotension (low blood pressure), acute kidney injury, and ototoxicity (damage to the ear).
The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
- Testing updates:
- As of today, 423 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 293 molecular tests and sample collection devices, 90 antibody and other immune response tests and 40 antigen tests. There are 66 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, three EUAs for antigen prescription at-home tests, 11 EUAs for antigen over-the-counter (OTC) at-home tests and three EUAs for molecular OTC at-home tests.
- The FDA has authorized 20 antigen tests and nine molecular tests for serial screening programs. The FDA has also authorized 689 revisions to test EUA authorizations.
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