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COVID-19 therapeutic updates
FDA approves Actemra (tocilizumab) injection for treatment of COVID-19 in certain hospitalized adults
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).
FDA first issued an EUA 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 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.
FDA has revised the EUA Letter of Authorization (PDF) and associated fact sheets to remove the population covered under the approved indication. Common side effects of Actemra and the recommended dosage for the approved population are included in the prescribing information (PDF). (December 21, 2022)
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Emergency Use Authorization (EUA) updates
New mpox diagnostic EUA
On December 23, 2022, FDA issued an EUA (PDF) for the VIASURE Monkeypox virus Real Time PCR Reagents for BD MAX System for the qualitative detection of DNA from monkeypox virus in human lesion swab specimens from individuals suspected of mpox by their health care provider. Emergency use of this test is limited to authorized laboratories. Learn more: Monkeypox (mpox) Emergency Use Authorizations for Medical Devices
COVID-19 in vitro diagnostic (test) EUAs
As of January 3, 2023, 443 tests and sample collection devices are authorized by FDA under EUAs. These include 298 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 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, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and 4 EUAs for molecular OTC at-home tests. FDA has authorized 43 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,196 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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January 11, 2023: Virtual Town Hall Series - Test Development and Validation During Public Health Emergencies (COVID-19 and mpox) (12:05 - 1:00 p.m. ET) - No registration required. There will be an opportunity to ask questions live on the call, and questions may also be submitted in advance by emailing CDRHWebinars@fda.hhs.gov.
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January 12, 2023: Virtual Public Listening Session to Identify Ambiguities, Gaps, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology (webinar, 1:00 p.m. ET) Also see: FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology
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January 26, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss the future vaccination regimens addressing COVID-19, including consideration of the composition and schedule of the primary series and booster vaccinations.
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April 24–27, 2023: 2023 Preparedness Summit - Recover. Renew: Reprioritizing All-Hazards Preparedness (Atlanta, GA) - Registration is now open, including virtual options.
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Information for industry and health care providers
Evusheld updates
FDA authorized (PDF) updates to the Evusheld (tixagevimab co-packaged with cilgavimab) EUA Fact Sheet for Health Care Providers (PDF) to add updated neutralization activity data against certain SARS-CoV-2 viral variants. The updated fact sheet is also available in Spanish (PDF). (December 21, 2022)
Shelf-life extension
On December 22, 2022, FDA granted an extension (PDF) of the shelf life of the authorized Pfizer-BioNTech COVID-19 Vaccine. FDA is extending the expiration date of the Pfizer-BioNTech COVID-19 Vaccine PBS/Sucrose formulation (supplied in multiple dose vials with purple caps). Cartons and vials of Pfizer-BioNTech COVID-19 Vaccine supplied in multiple dose vials with purple caps with an expiry date of December 2021 through December 2022 printed on the label may remain in use beyond the printed date until the updated expiry date shown here, as long as approved storage conditions noted in the updated fact sheet for health care providers (PDF) have been maintained. Learn more, and check shelf-life extensions for other medical countermeasures: Expiration Dating Extension.
Certain reworked Philips Respironics Trilogy 100/200 Ventilators recalled due to potential for silicone foam adhesion failure and residual PE‐PUR foam debris
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. (December 22, 2022)
FDA is committed to providing timely recommendations, regulatory information, guidance, and technical assistance necessary to support rapid COVID-19 response efforts. FDA has issued more than 75 COVID-19-related guidances to date.
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In case you missed it
BAA: Don't delay!
FDA funds extramural research through an agency-wide Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. For consideration in FY 2023, BAA white papers are due by 5:00 p.m. EST, January 23, 2023. Also see: MCM-related research areas of interest
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It's a good time to get your flu vaccine
Influenza (flu) viruses typically spread in fall and winter, with activity peaking between December and February. Getting vaccinated now can lower your chances of getting the flu. Find a flu shot near you. (Tip: You can get your updated COVID-19 vaccine booster at the same time!)
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 350 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.
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FDA Medical Countermeasures Initiative (MCMi) News)
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