FDA Roundup: November 22, 2022 – FDA.gov

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

• Today, the FDA issued an emergency use authorization (EUA) for the Lucira COVID-19 and Flu Test for use in a point-of-care (POC) setting, following collaboration with the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP). “This authorization demonstrates our continued commitment to expand the availability of multiplex tests for COVID-19 and flu and provide a streamlined approach to developers to increase the availability of these types of tests,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We will continue to work with developers and our government colleagues to ensure the public has access to appropriately accurate and reliable tests they can count on and we stand ready to authorize additional multi-analyte tests, including at-home tests, to meet current public health testing needs.” The Lucira COVID-19 and Flu Test is a single use molecular test intended for detection of both the SARS-CoV-2 virus and influenza (A or B) if a patient is suspected of respiratory viral infection consistent with COVID-19. The test can be used in persons aged two years or older and is collected by nasal swab by a health care provider in a POC setting. Negative test results should be confirmed with another FDA-authorized molecular test. Negative test results must be combined with clinical observations, patient history and epidemiological information.
• Today, the FDA provided updated information about medical device reports received from Aug. 1 to Oct. 31, 2022, that are reportedly associated with the breakdown or suspected breakdown of the polyester-based polyurethane (PE-PUR) foam used in the Philips Respironics ventilators, BiPAP machines, and CPAP machines included in the recall announced in June 2021. Since April 2021, the FDA has received more than 90,000 medical device reports, including 260 reports of death, reportedly associated with the PE-PUR foam breakdown or suspected foam breakdown. The FDA will continue to update the public about the status of the Philips Respironics’ recall announced in June 2021.
• On Monday, the FDA posted warning letters to five companies for illegally selling products containing cannabidiol (CBD). These companies are selling CBD containing products that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD. CBD-containing products in forms that are appealing to children, such as gummies, hard candies and cookies, are especially concerning.
• On Monday, the FDA authorized the Fastep COVID-19 Antigen Home Test (manufactured by Azure Biotech Inc.), an over-the counter (OTC) COVID-19 antigen diagnostic test that shows results in 15 minutes. The test can be used as a serial test for people within the first five days of symptom onset or for people who do not have symptoms. The Fastep test was validated with data that was gathered through the FDA’s collaboration with the NIH ITAP.
• On Monday, the FDA authorized the CorDx COVID-19 Antigen Test (manufactured by CorDx, 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 seven days of symptom onset or for people who do not have symptoms.
• On Friday, the FDA announced it will hold a public meeting on Dec. 7, 2022, to offer opportunity for comment on the proposed recommendations for reauthorization of the Animal Drug User Fee Act (ADUFA). Interested parties can share their comments at the meeting or by submitting them to the public docket. ADUFA gives the FDA the authority to collect user fees that provide supplemental funding to support the new animal drug review process. The FDA’s responsibility is to ensure these drugs are safe and effective and ADUFA program resources enhance the timeliness and predictability of application review for animal drugs needed by various animal populations. Reauthorization of this program includes an annual revenue of at least $32 million in user fees, supplementing budget authority funding for the new animal drug program. The current user fee program expires Sept. 30, 2023. To attend or provide comment at the meeting, please register here.
• On Friday, the FDA issued an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products that appear on the FDA’s drug shortage list by a licensed pharmacist in a state-licensed pharmacy or federal facility. The guidance describes steps to reduce the risk of cross-contamination between these and other products. Beta-lactam drugs can cause life-threatening allergic reactions in some patients.

  Amoxicillin is widely used for the treatment of bacterial infections in children, among other uses. Antibiotics like amoxicillin treat many different infections caused by bacteria, but they are not effective against viral infections like the common cold, most sore throats, and the flu.

• COVID-19 testing updates:
  • As of today, 439 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 300 molecular tests and sample collection devices, 85 antibody and other immune response tests, 53 antigen tests, and 1 diagnostic breath test. There are 78 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, 21 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 for molecular OTC at-home tests.
  • The FDA has authorized 37 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1162 revisions to EUA authorizations 

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