FDA Roundup: December 23, 2022

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Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

On Monday, the FDA announced that the VQIP Application Portal would open on January 1, 2023 for benefits during fiscal year (FY) 2024. VQIP is a voluntary fee-based program that provides importers, who achieve and maintain control over the safety and security of their supply chains, the benefits of expedited review and importation of human and animal foods into the United States.
On Wednesday, the FDA approved a new indication for Actemra (tocilizumab) injection for the treatment of hospitalized adult patients with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
The FDA first issued an emergency use authorization for Actemra in hospitalized adult and pediatric patients (2 years of age and older) for the same use on June 24, 2021. Actemra remains authorized for emergency use for the treatment of COVID-19 in hospitalized pediatric patients 2 to less than 18 years of age who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information.
On Thursday, the FDA issued a safety communication to provide additional information to patients, caregivers, and health care providers about two recent issues in certain reworked Philips Respironics (Philips) Trilogy 100 and Trilogy 200 ventilators. These Philips Trilogy 100 and Trilogy 2000 ventilators were recalled in June 2021 for issues with the polyester-based polyurethane (PE-PUR) sound abatement foam breakdown. The silicone foam material used to replace the PE-PUR foam in the reworked ventilators may potentially move and block the airpath, which may reduce air flow in the ventilator and could also cause the device to alarm. Additionally, Philips observed residual PE‐PUR sound abatement foam in some reworked Trilogy 100 and Trilogy 200 ventilators that were returned to customers.
On Thursday, the FDA issued emergency use authorizations (EUAs) for two additional OTC at-home COVID-19 Tests, for ages 14 years or older with a self-collected nasal swab sample or age 2 years or older when an adult collects the nasal swab sample:
- The Advin COVID-19 Antigen Test @Home (manufactured by Advin Biotech Inc.), an OTC COVID-19 antigen diagnostic test that shows results in 10 minutes. The test can be used as a serial test for people within the first 7 days of symptom onset or for people who do not have symptoms.
- The ASSURE-100 Rapid COVID-19 Home Test (manufactured by Oceanit Foundry LLC), an OTC COVID-19 antigen diagnostic test that shows results in 20 minutes. The test can be used as a serial test for people within the first 7 days of symptom onset or for people who do not have symptoms.
These tests should always be repeated if a negative result is found:
- Test at least 2 times over 3 days with at least 48 hours between tests if the person has symptoms, or
- Test at least 3 times over 5 days with at least 48 hours between tests if the person does not have symptoms.
The EUAs issued for these tests represent the FDA’s ongoing commitment to increase the availability of appropriately accurate and reliable at-home COVID-19 diagnostic tests, and to facilitate access to these tests for all Americans.
COVID-19 testing updates:
- As of today, 440 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 297 molecular tests and sample collection devices, 85 antibody and other immune response tests, 57 antigen tests, and 1 diagnostic breath test. There are 79 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 24 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
- The FDA has authorized 41 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1186 revisions to EUA authorizations.