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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 Tuesday, the FDA updated the FAQs on Testing for SARS-CoV-2 to note that no tests remain on the commercial manufacturer serology test notification list described in the FDA’s Policy for Coronavirus Disease-2019 Tests. All tests previously on the commercial manufacturer serology test notification list have either been issued an Emergency Use Authorization or should no longer be distributed, marketed, or offered.
- On Wednesday, the FDA announced the fiscal year 2023 fee rates and payment procedures under the Animal Drug User Fee Amendments of 2018 (ADUFA IV) and Animal Generic Drug User Fee Amendments of 2018 (ADUFA III).
- On Wednesday, the FDA announced fiscal year 2023 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program, and accreditation and certification bodies interested in participating in the Accredited Third-Party Certification Program. The user fee rates are authorized by the FDA Food Safety Modernization Act and allow the agency to assess and collect fees to cover the FDA’s cost of administering these programs.
- On Thursday, the FDA posted a Consumer Update on how gene therapy can be used to modify genes or replace faulty genes with healthy ones to treat, cure, or prevent a disease or medical condition. The FDA has approved multiple gene therapy products for cancer and rare diseases.
- 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 302 molecular tests and sample collection devices, 85 antibody and other immune response tests, 51 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, 19 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
- The FDA has authorized 30 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1061 revisions to EUA authorizations.
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