• February 22, 2023: MCMi email - COVID-19 EUA updates | Join us for a March 9 Grand Rounds on microphysiological systems and Zika research

• February 15, 2023: FDA and HHS/ASPR authorized an additional extension to the shelf-life for all lots of the refrigerated GSK monoclonal antibody, sotrovimab, from 24 months to 30 months. Retained product must be appropriately held in accordance with storage conditions detailed in the authorized Fact Sheet for Health Care Providers (PDF, 1.4 MB) and the Letter of Authorization (PDF, 375 KB). The extended expiry date for each lot can be found in Table 1 here.  

• February 15, 2023: MCMi email - New report: Learn how FDA supports development of & access to medical countermeasures

• February 15, 2023: MCMi Fiscal Year 2022 Program Update - FDA plays a critical role in protecting the United States from chemical, biological, radiological, and nuclear threats, and emerging infectious diseases, like COVID-19 and mpox. This report provides updates on fiscal year 2022 activities FDA-wide to support medical countermeasure-related public health emergency preparedness and response. View the PDF (1.5 MB).

• February 10, 2023: FDA issued an EUA (PDF, 299 KB) for the Cepheid Xpert Mpox test for use in a point-of-care (POC) setting. Validation data was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The Xpert Mpox test is a real-time polymerase chain reaction (PCR) test intended to detect monkeypox virus DNA in lesion swab specimens from individuals suspected of mpox by their health care provider. 

• February 10, 2023: Update on Expiration Date Extensions of Certain Lots of Doxycycline Hyclate 100 mg Capsules Held in Strategic Stockpiles (PDF, 221 KB) - On February 1, 2023, FDA issued a memo to government public health and emergency response stakeholders providing an important update about expiration date extensions of certain lots of doxycycline hyclate 100 mg capsules manufactured by West-Ward Pharmaceuticals held in strategic stockpiles for anthrax emergency preparedness and response purposes. Also see: Expiration date extensions of certain lots of doxycycline hyclate

• February 9, 2023: FDA updates draft guidance to help increase supply of children’s ibuprofen - FDA has revised the immediately-in-effect guidance on compounding certain ibuprofen oral suspension products. The revision addresses outsourcing facilities providing certain ibuprofen oral suspension products to state-licensed pharmacies (including those within hospitals and health systems) and applicable federal facilities to dispense to patients for home use, following receipt of a valid, patient-specific prescription from a health care provider. FDA published this revision to address continual increased demand for fever and pain-reducing medications outside of hospitals and health systems. 

• February 8, 2023: Summary report (PDF, 110 KB) of the Dec. 2022 Joint EMA-FDA workshop on the efficacy of monoclonal antibodies in the context of rapidly evolving SARS-CoV-2 variants

• February 8, 2023: MCMi email - Report your COVID-19 at-home test results | Now hiring: Regulatory Counsel

• February 6, 2023: Job opening - Regulatory Counsel (PDF, 322 KB) (Title 21, Cures Band C) - Join the FDA Office of Counterterrorism and Emerging Threats (OCET), offering legal, regulatory, and policy expertise to help support medical countermeasure development and availability. Applications are due by March 15, 2023 (deadline extended).

• February 6, 2023: 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. Learn more: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results

• February 3, 2023: FDA cleared 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. This test was cleared through the Dual 510(k) and CLIA Waiver pathway, making it the first COVID-19 test to be given a CLIA Waiver. 

• February 1, 2023: FDA revised the Letters of Authorization for two EUAs, Paxlovid (PDF, 283 KB) and Lagevrio (PDF, 286 KB), 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. Additional information is available on the EUA page.

• February 1, 2023: 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: MCMi email - COVID-19 therapeutics update: Evusheld not currently authorized in U.S. | Watch out for illegally sold mpox products

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