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FDA Roundup: June 28, 2022

For Immediate Release:

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

  • Today, the FDA and HHS/ASPR announced the authorization of an extension to the shelf-life from 18 months to 24 months for specific lots of the refrigerated AstraZeneca monoclonal antibody, Evusheld (tixagevimab co-packaged with cilgavimab), which is currently authorized for emergency use for pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals. The agency granted this extension following a thorough review of data submitted by AstraZeneca. As a result of this extension, some batches may be stored for an additional 6 months from the labeled date of expiry (see Table 1 here). This extension applies to all unopened vials of Evusheld that have been held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers and the EUA Letter of Authorization for Evusheld. As required by the emergency use authorization for Evusheld, unopened vials of Evusheld (150 mg/1.5 mL of tixagevimab and 150 mg/1.5 mL of cilgavimab), must be stored under refrigerated temperature at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light.
  • Today, the FDA provided an update on the Digital Health Center of Excellence’s (DHCoE) activities, meetings, webinars, collaborations, and hiring efforts. This update highlights DHCoE activities that promote awareness and consistent application of digital health regulatory policies to foster equity in health care; pioneer the development and enhancement of digital health regulatory paradigms; and cultivate digital health-focused collaborations. Discover how CDRH’s Digital Health Center of Excellence is helping set the stage for the advancement of digital health technologies to help protect and promote public health.
  • On Monday, the FDA published a Consumer Update on how the agency’s approval process ensures that generic medicines are as safe and effective as their brand counterparts. FDA-approved generic drugs, like their brand counterparts, have met strict approval standards. Today, about 9 in 10 prescriptions filled in the U.S. are for generic drugs. 
  • On Monday, the FDA authorized an extension to the shelf-life from 24 months to 30 months for specific lots of the refrigerated Regeneron monoclonal antibodies, casirivimab and imdevimab, administered together or REGEN-COV. Due to the high frequency of the Omicron variant and its subvariants, REGEN-COV is not currently authorized in any U.S. region. Therefore, REGEN-COV may not be administered for treatment or post-exposure prevention of COVID-19 under the Emergency Use Authorization until further notice by the Agency. However, it is the recommendation of the U.S. Government that product be retained in the event that future SARS-CoV-2 variants, which may be susceptible to REGEN-COV, emerge and become prevalent in the U.S.
  • On Monday, the FDA announced a new webinar to share a case study of the agency’s recent review of genome-edited beef cattle under the agency’s risk-based review process for Intentional Genomic Alterations (IGAs) in animals that may pose low risk. The FDA is also providing revamped web resources for animal biotechnology products. 
  • On Monday, the FDA announced a virtual public meeting on the FDA’s oversight of advanced manufacturing technologies for animal drugs, which will provide stakeholders with an opportunity to share information and insight on this topic with the FDA.
  • 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 1016 revisions to EUA authorizations
       

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


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