July 1, 2022 - FDA Roundup: July 1, 2022

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

• Today, the FDA announced a request for nominations for consumer representatives to serve on advisory committees and panels for which vacancies currently exist or are expected to occur in the near future. The FDA relies on our many advisory committees to help us make sound decisions based on the best science available. The agency seeks to include the views of individuals on its advisory committee regardless of their gender identification, religious affiliation, racial and ethnic identification, or disability status and, therefore, encourages nominations of appropriately qualified candidates from all groups. Nominations from individuals, and consumer organizations interested in participating in the selection process should be submitted to the FDA by Aug. 15, 2022.
• On Thursday, the FDA's Center for Veterinary Medicine released both a status update on Phase I of its five-year action plan for Supporting Antimicrobial Stewardship in Veterinary Settings, as well as a report to describe some of the data that the FDA and federal partners collect regarding antimicrobial sales, use, and resistance in U.S. animal agriculture and the related food chain.
• On Wednesday, the FDA revised the Evusheld Fact Sheet for Healthcare Providers to recommend repeat dosing every six months with a dose of 300 mg of tixagevimab and 300 mg cilgavimab if patients need ongoing protection. The previous Fact Sheet for Healthcare Providers did not provide a specific recommendation on the dosing interval. Nonclinical data and pharmacokinetic modeling suggest that activity against the currently circulating SARS-CoV-2 variants and subvariants may be retained for six months at drug concentrations achieved following an Evusheld dose of 300 mg of tixagevimab and 300 mg cilgavimab. We continue to monitor the neutralizing activity of Evusheld against emerging SARS-CoV-2 variants and will provide additional updates as needed.
• On Tuesday, the FDA approved the Beyond Air, Inc. LungFit PH, the first device to generate nitric oxide gas from room air in conjunction with a ventilator to treat pulmonary hypertension (PH). It is intended for newborn infants at least 34 weeks gestation with certain types of respiratory failure to improve oxygenation. Persistent PH in newborns is a serious condition that occurs when the blood vessels in the baby's lungs do not open enough after birth, which limits how much oxygen is sent to the brain and organs. About one in every 1,250 babies is diagnosed with this condition, and risk factors include difficult birth, birth asphyxia, infections such as pneumonia, and problems with the heart or lungs.
• COVID-19 testing updates:
  • As of today, 438 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 303 molecular tests and sample collection devices, 85 antibody and other immune response tests, 49 antigen tests, and 1 diagnostic breath test. There are 80 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, 17 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 for molecular OTC at-home tests.
  • The FDA has authorized 27 antigen tests and 8 molecular tests for serial screening programs. The FDA has also authorized 1021 revisions to EUA authorizations.

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