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The latest from FDA
COVID-19 therapeutics update
FDA announces Evusheld is not currently authorized for emergency use in the U.S.
On January 26, 2023, FDA revised the Emergency Use Authorization (EUA) for Evusheld (tixagevimab co-packaged with cilgavimab) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is less than or equal to 90%. Based on this revision, Evusheld is not currently authorized for use in the U.S. until further notice by the Agency.
Should a patient become infected with SARS-CoV-2 and develop symptoms of COVID-19, they should seek medical attention, including starting treatment for COVID-19 as appropriate. There are several treatments – Paxlovid, Veklury (remdesivir) and Lagevrio (molnupiravir) – that are expected to work against currently circulating variants, and that are authorized or approved to treat certain patients with mild-to-moderate COVID-19 who are at high risk for progression to severe disease, including hospitalization or death. Health care providers should assess whether treatments are right for their patients. Also see: Important prescribing information for health care providers (PDF)
The U.S. Government recommends that facilities and providers with Evusheld retain all product in the event that SARS-CoV-2 variants which are neutralized by Evusheld become more prevalent in the U.S. in the future. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF) and the Letter of Authorization (PDF). Also see: Expiration Dating Extension - COVID-19 Therapeutics
Mpox response update
Watch out for illegally sold mpox products
On January 31, 2023, FDA issued warning letters to five companies for illegally selling products for treating or preventing human monkeypox (mpox). There are no FDA-approved treatments for mpox. FDA approved the Jynneos vaccine for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection. At this time, public health authorities have not recommended the general public needs to be vaccinated against mpox. Consumers concerned about mpox should consult their health care provider.
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Emergency Use Authorization (EUA) updates
COVID-19 in vitro diagnostic (test) EUAs
As of January 31, 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 44 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,217 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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February 9, 2023: FDA Grand Rounds: A Modular Approach for Enhanced Plasmid Subtyping and AMR Gene Profiling of Plasmids (webcast, 12:00 - 1:00 p.m. ET) - Plasmids are a major factor in the spread of antimicrobial resistance genes. Current plasmid typing methods do not account for the great degree of genetic diversity associated with the recombination mechanisms that allow plasmids to acquire antimicrobial resistance genes. In this presentation, Lucas Harrison, Ph.D., FDA Center for Veterinary Medicine (CVM), introduces an enhanced plasmid subtyping method that not only identifies the genetic elements exclusive to and indicative of a plasmid type, but also characterizes plasmids based on the DNA sequence and relative position of these genetic elements as they are rearranged through plasmid recombination mechanisms.
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February 15, 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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February 17, 2023: Application of Artificial Intelligence and Machine Learning for Precision Medicine (virtual) - Hosted in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), this workshop will review current methodologies, opportunities, challenges, and best practices to address the rapidly changing landscape of artificial intelligence and machine learning in the setting of drug development and precision medicine. Advance registration required.
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April 24-28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Maryland or virtual) - Save the date! Registration will open in February 2023.
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Information for industry and health care providers
Emergent recalls certain RSDL kits due to leak potential
Emergent is recalling RSDL (Reactive Skin Decontamination Lotion) kits from a specific batch after customers noted that some packets were leaking. The leak in the package could cause the lotion-bearing sponge to be less effective when used to remove or neutralize chemical warfare agents. Users also may be unnecessarily exposed to the lotion from leaked packages.
The RSDL kit is an easy-to-open packet containing a sponge soaked with lotion. The RSDL kit is carried by members of the military and is intended to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin.
FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries and/or serious health consequences. (January 26, 2023)
Biosimilar research roadmap
On January 25, 2023, FDA's Center for Drug Evaluation and Research (CDER) released the BsUFA III Regulatory Science Pilot Program: Research Roadmap (PDF) to provide additional information about the biosimilar regulatory science research pilot program. FDA also opened a public docket to gather feedback on this roadmap; comments are requested by April 5, 2023.
The Biosimilar User Fee Amendments (BsUFA) facilitate the development of safe and effective biosimilars and interchangeable biosimilars for patients by supporting FDA review of biosimilar submissions. The roadmap highlights research areas where advancement is expected to impact science-based recommendations and regulatory decision making. Learn more: www.fda.gov/biosimilars
Update on in-person face-to-face formal meetings with FDA
Beginning February 13, 2023, CDER and CBER will restart in-person, face-to-face industry meetings (with a hybrid component). This change will start with Type A, BPD Type 1, and Type X meeting requests due to the initially limited availability of upgraded conference rooms. Other types of face-to-face meetings—should the agency approve requests for those meetings—will be held fully virtually (i.e., the in-person format will not be considered).
The agency will not convert existing meeting requests received or scheduled before February 13, 2023, to the in-person format in order to fairly implement the transition. Learn more
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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
What happens to EUAs when a public health emergency ends?
There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ (updated January 31, 2023).
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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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