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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
More FDA press announcements
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Diagnostic updates
FDA's Diagnostic Data Program: Advancing data harmonization, quality, and analytics
FDA provided an update about the Diagnostic Data Program advancing the FDA's mission and goals. The program has made substantial progress toward harmonizing diagnostic data, enhancing data quality, and creating analytics tools to optimize data use. Visit the website to learn more about opportunities to engage in these efforts, including applying for future funding. FDA is also working with numerous stakeholders through the SHIELD Collaborative Community and encourages interested parties to engage in this effort. (February 23, 2024) |
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First OTC, at-home antigen test that detects both flu and COVID-19 viruses
FDA issued an EUA for SEKISUI Diagnostics, LLC’s OSOM Flu SARS-CoV-2 Combo Home Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests. The test is authorized for people aged 14 years or older with self-collected anterior (nares) nasal swab specimens and those aged two years or older when an adult collects the nasal swab specimens. The OSOM Flu SARS-CoV-2 Combo Home Test is the first over-the-counter (OTC) at-home antigen test that detects both flu and COVID-19 viruses to receive an EUA following collaboration with the National Institutes of Health Independent Test Assessment Program. (February 29, 2024)
Antimicrobial susceptibility test clearance
FDA cleared the PBC [positive blood culture] Separator with Selux Antimicrobial Susceptibility Testing (AST) System from Selux Diagnostics, Inc. to be marketed in the U.S. The PBC Separator with Selux AST System is an automated lab inoculation preparation system intended for use with positive blood culture samples that can be used for quantitative in vitro antimicrobial susceptibility testing without the traditional overnight subculture.
In 2021, FDA granted Breakthrough Device designation to this system because it represented a breakthrough technology that could help provide more effective treatment for a life-threatening or irreversibly debilitating condition, among other criteria. This marketing clearance reflects the FDA’s ongoing commitment to advance access to safe and effective antimicrobial susceptibility testing intended to aid health care professionals in making more rapid and informed decisions for patients. (February 15, 2024)
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Emergency Use Authorization (EUA) updates
Reminder: Paxlovid expiration dates
On January 29, 2024, FDA announced a revision to the Paxlovid EUA, stating that Paxlovid manufactured and labeled in accordance with the EUA (EUA-labeled Paxlovid) currently in U.S. distribution will remain authorized for use through the labeled or extended expiration date, as applicable, or through March 8, 2024, whichever is earlier. Both providers and patients should visit Pfizer’s website for information on lots of EUA-labeled Paxlovid that are the subject of a shelf-life extension. Lots of EUA-labeled Paxlovid not listed on Pfizer’s website may only be used through the labeled expiration date, or through March 8, 2024, whichever is earlier.
EUA revocations
FDA revoked the following EUA for the reasons noted in the revocation letter (PDFs):
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.
EUA quick links
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Events
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March 5, 2024: Advancing the Use of Complex Innovative Designs in Clinical Trials: From Pilot to Practice (Silver Spring, MD and virtual) - To discuss aspects of complex adaptive, Bayesian, and other novel clinical trial designs.
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March 5, 2024: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2024 to 2025 influenza season.
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March 7, 2024: Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes (virtual) - To discuss how and when to work with FDA to improve your integrated safety analyses and obtain answers to questions you may have about your application. In addition, common mistakes seen in integrated analyses will be discussed to help you avoid making the same mistakes.
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March 19-20, 2024: Enhancing Adoption of Innovative Clinical Trial Approaches (Washington, DC and virtual) - To discuss efforts to advance innovation of clinical trial design and conduct. Please register to attend in-person or virtually.
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April 15-19, 2024: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Galveston, TX or virtual) - To discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in BSL-4 facilities. Pre-register to attend in person by March 20, 2024, or by March 29, 2024 to attend virtually.
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May 16, 2024: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.
More events: FDA Meetings, Conferences and Workshops
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Information for industry and health care providers
Guidance and updates for industry
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- February 21, 2024: Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment - This final guidance supersedes the guidance of the same name initially published in September 2020. It provides sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adults and adolescents. This guidance also provides a set of common COVID-19-related symptoms as an example as well as an approach to their measurement for use in clinical trials. Although the public health emergency has ended, FDA is committed to supporting continued development of products to treat or prevent the COVID-19 virus by providing timely guidance to assist continued efforts in the post-pandemic era.
- February 20, 2024: Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions: FDA Reminds Medical Device Manufacturers to Scrutinize Third-Party-Generated Data - FDA is reminding sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA. The FDA has identified an increase in submissions containing unreliable data generated by third-party test labs, including from numerous facilities based in China and India. This alarming trend has resulted in the FDA being unable to reach a substantial equivalence determination or otherwise authorize marketing for medical devices whose submissions include such data.
- February 16, 2024: Charging for Investigational Drugs Under an IND: Questions and Answers - This final guidance responds to frequently asked questions about FDA’s processes, policies and regulation regarding charging patients for investigational new drugs under certain circumstances in clinical trials or expanded access for treatment use.
- February 13, 2024: Use of Data Monitoring Committees in Clinical Trials - This draft guidance provides recommendations to help sponsors of clinical trials determine (1) when a data monitoring committee (DMC) (also known as a data and safety monitoring board (DSMB) or a data and safety monitoring committee (DSMC) or an independent data monitoring committee (IDMC)) would be useful for clinical trial monitoring and (2) what procedures and practices they should consider to guide their operations. When finalized, this guidance will supersede the final guidance for clinical trial sponsors titled “Establishment and Operation of Clinical Trial Data Monitoring Committees,” issued in March 2006. Submit comments by April 15, 2024.
- February 12, 2024: FDA extended the comment period for the advanced manufacturing technologies designation program draft guidance. Comments must be submitted by March 13, 2024.
Expiration date extension
Did you know? You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions.
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In case you missed it
Quick COVID-19 resources
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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. Also see, from HHS, Fact Sheet: End of the COVID-19 Public Health Emergency
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 650 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.
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FDA Medical Countermeasures Initiative (MCMi) News)
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