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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
- February 7, 2023: FDA Roundup including clearance of the BioFire SPOTFIRE Respiratory (R) Panel, an in vitro diagnostic test used for the simultaneous detection and identification of multiple respiratory viral and bacterial infections in individuals suspected of having COVID-19 or other respiratory tract infections
- February 3, 2023: FDA Roundup including an alert to consumers not to purchase and immediately stop using EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.
Quick links: COVID-19 updates from FDA, FDA Mpox Response
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COVID-19 therapeutics update
COVID-19 EUA testing requirement change
On February 1, 2023, FDA revised the Letters of Authorization for two EUAs, Paxlovid (PDF) and Lagevrio (PDF), to remove the requirement for positive test results to prescribe these products. The agency continues to recommend that providers use direct SARS-CoV-2 viral testing to help diagnose COVID-19.
However, we recognize that, in rare instances, individuals with a recent known exposure (e.g., a household contact) who develop signs and symptoms consistent with COVID-19 may be diagnosed by their health care provider as having COVID-19 even if they have a negative direct SARS-CoV-2 viral test result. In such instances, their health care provider may determine that treatment with authorized therapeutics may be appropriate if the patient reports mild-to-moderate symptoms of COVID-19 and is at high risk for progression to severe COVID-19, including hospitalization or death, and the terms and conditions of the product’s authorization are met.
Related updated information for health care providers (PDFs):
Report your at-home COVID-19 test result
MakeMyTestCount.org
FDA is updating its easy step-by-step guide to include information about reporting your over-the-counter (OTC) at-home COVID-19 test result to MakeMyTestCount.org.
FDA encourages you to voluntarily and anonymously report your positive or negative test results every time you use an at-home COVID-19 test. You can report your test result by going to MakeMyTestCount.org or by using an app or other digital option for self-reporting that may be included with your test. Report each test result only one time.
The data from MakeMyTestCount.org can help public health departments know how fast the virus is spreading. This valuable test data helps public health departments assess and modify their response to COVID-19 in their local communities, states, or across the country. The MakeMyTestCount website is developed through the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program and allows consumers to anonymously report the results of OTC at-home COVID-19 test.
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Join FDA's Medical Countermeasures Initiative (MCMi)
Job opening: Regulatory Counsel (Title 21, Cures Band C)
Apply to join the FDA Office of Counterterrorism and Emerging Threats (OCET) in the position of Regulatory Counsel, offering legal, regulatory, and policy expertise to help support medical countermeasure development and availability. For more information, see the job posting (PDF). Applications are due by February 24, 2023.
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Emergency Use Authorization (EUA) updates
EUA revocations
FDA revoked EUAs for these tests for the reasons noted in the revocation letters:
Information about revoked EUAs is available on the web page Emergency Use Authorization--Archived Information. For revoked device EUAs, see: Historical Information about Device Emergency Use Authorizations.
COVID-19 in vitro diagnostic (test) EUAs
As of February 7, 2023, 440 tests and sample collection devices are authorized by FDA under EUAs. These include 296 molecular tests and sample collection devices, 85 antibody and other immune response tests, 58 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, 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 1,221 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics
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Events
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New! February 8, 2023: The House Committee on Energy and Commerce; Subcommittees on Oversight and Investigations and Health will hold a hearing, The Federal Response to COVID-19 (10:00 a.m. ET). FDA Commissioner Dr. Robert M. Califf will testify along with other leaders from across HHS.
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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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New! February 28-March 1, 2023: Vaccines and Related Biological Products Advisory Committee meeting (webcast) - The committee will meet in open session to discuss and make recommendations on the safety and effectiveness of two respiratory syncytial virus (RSV) vaccine Biologics License Applications (BLAs).
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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
Shelf-life extension for specific lots of Paxlovid
The Administration for Strategic Preparedness and Response (ASPR) and FDA announced the authorization of a shelf life extension to 24 months for the Pfizer antiviral therapy, Paxlovid (nirmatrelvir tablets and ritonavir tablets co-packaged for oral use), which is currently authorized for emergency use for the treatment of mild-to-moderate COVID-19 in certain adults and pediatric patients (12 years of age and older weighing at least 40kg).
As a result of this extension, be sure to check all inventory for the extended expiration dates. As required by the emergency use authorization, unopened cartons of Paxlovid (300 mg nirmatrelvir and 100 mg ritonavir, or 150 mg nirmatrelvir and 100 mg ritonavir), must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF). FDA granted this extension following a thorough review of data submitted by Pfizer. To find out the expiry date extension on your product, please download the data tables.
This update is in addition to the Paxlovid shelf-life extension information announced on September 6, 2022. (January 18, 2023)
New draft guidance for industry
FDA issued a draft guidance for industry, Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products. This guidance makes recommendations to sponsors and investigators considering the use of externally controlled clinical trials to show evidence of the safety and effectiveness of a drug.
The guidance provides stakeholders with considerations for designing and conducting externally controlled trials that use patient-level data (i.e., information on individual people, such as medical and treatment history) to study the effectiveness and safety of drugs, including threats to the validity of trial results from sources of potential bias. The external data can include data from other clinical trials or from real-world data sources such as registries, electronic health records, or medical claims. This guidance also describes considerations for communicating with FDA and ensuring the agency has access to data from an externally controlled trial.
This draft guidance is part of a series of guidances FDA has already published, or plans to publish, as part of the agency’s Real-World Evidence Program and in support of the 21st Century Cures Act and the Prescription Drug User Fee Act. Submit comments by May 2, 2023. (February 1, 2023)
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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Update your antibodies
The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 380 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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