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Coronavirus Disease 2019 (COVID-19) updates
Updates from FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include:
Bookmark www.fda.gov/coronavirus for the latest.
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COVID-19 test safety alert
Do not use E25Bio COVID-19 Tests: FDA safety communication
FDA is warning people not to use the E25Bio COVID-19 Direct Antigen Rapid Test. This test has not been authorized, cleared, or approved by the FDA for distribution or use in the United States, and it may include false labeling representing that the test is authorized by the FDA. The E25Bio COVID-19 Direct Antigen Rapid Test may also be sold under the trade name E25Bio SARS-CoV-2 Antigen Test Kit.
The FDA is concerned about the risk of false results when using this test because E25Bio has not provided the FDA with adequate data demonstrating that the test’s performance is accurate. In addition, the FDA is aware that the E25Bio COVID-19 Direct Antigen Rapid Test (DART) was sold directly to consumers and may have been accompanied by labeling with instructions for collecting a sample from deep inside the nose, reaching the back of the throat (nasopharyngeal) or from the middle part of the throat (pharynx) just beyond the mouth (oropharyngeal), which could result in serious injury when this is not done by trained professionals.
The FDA has not received reports of injuries, adverse health consequences, or death associated with use of the E25Bio COVID-19 Direct Antigen Rapid Test. (February 4, 2022)
COVID-19 Lessons Learned: Clinical Evaluation of Therapeutics
Report issued by the Reagan-Udall Foundation for the FDA
The Reagan-Udall Foundation for the FDA, at the request of the FDA, has released a report that outlines initial lessons learned from the federal government’s and research communities’ COVID-19 response and provides actionable recommendations to enhance the scope, prioritization, and communication of research activities within the context of a public health emergency. (February 4, 2022)
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Regulatory science update
Using real-world evidence to advance COVID-19 medical countermeasures
The rapid assessment of inpatient treatments has emerged as particularly critical for effective COVID-19 care, because the majority of life-threatening cases of COVID-19 are treated in inpatient settings. An FDA-funded extramural research project aims to develop a system of studies for the rapid assessment of the safety and effectiveness of COVID-19 inpatient medical countermeasures using real-world evidence (RWE). (February 7, 2022)
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Emergency Use Authorization (EUA) updates
SARS-CoV-2 viral mutations: Impact on COVID-19 tests
Please bookmark and check this web page often for updates on how viral mutations, including the omicron variant, impact COVID-19 tests: SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests.
In vitro diagnostic (test) EUAs
As of February 8, 2022, 421 tests and sample collection devices are authorized by FDA under EUAs. These include 291 molecular tests and sample collection devices, 85 antibody and other immune response tests, and 45 antigen tests. There are 69 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for molecular prescription at-home test, 3 EUAs for antigen prescription at-home tests, 14 EUAs for antigen over-the-counter (OTC) at-home tests, and 3 EUAs for molecular OTC at-home tests. FDA has authorized 26 antigen tests and 9 molecular tests for serial screening programs. The FDA has also authorized 812 revisions to test EUA authorizations. Also see: Coronavirus Testing Basics
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Events
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February 9, 2021: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET, hosted by FDA's Center for Devices and Radiological Health (CDRH). FDA will host an additional event in this series on February 23, 2022.
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February 15, 2022: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss to discuss the request for EUA of the Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age.
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February 22, 2022: Webinar on Draft Guidances on Transition Plans for COVID-19 Related Medical Devices, 1:00 - 2:30 p.m. ET
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March 3, 2022: 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 2022-2023 influenza season.
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March 7-9, 2022: FDA, the Medicines and Healthcare products Regulatory Agency (MHRA), and Health Canada Good Clinical Practice Workshop: Global Clinical Trials - Considerations and Lessons Learned from the Changing Landscape (virtual)
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April 25-29, 2022: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - register by March 25, 2022
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Information for industry and health care providers
Extended comment period for draft guidance on 506J notifications for medical devices
FDA announced that the comment period for the draft guidance: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act, published on January 11, 2022, has been extended by 30 days, and will close on April 11, 2022.
Guidance for industry
FDA issued a guidance, Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the COVID-19 Pandemic, to help sponsors mitigate the challenges related to the constrained supply of nonhuman primates (NHPs) available for conducting nonclinical toxicity assessments, which has arisen as a consequence of the current COVID-19 pandemic. (February 4, 2022)
Because of significant concerns for human safety, FDA issued a guidance, COVID-19 Public Health Emergency: Policy on COVID-19-Related Sanitation Tunnels, to announce a policy discouraging sponsors from developing or seeking approval or authorization for the use of sanitation tunnels, which are tunnels, walkways, chambers, and similar systems that spray humans with a mist of disinfectant or aerosolized antiseptic with the aim of preventing or treating COVID-19. (February 8, 2022)
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
Find a COVID-19 vaccine or booster near you
Text your zip code to GETVAX (438829) in English or VACUNA (822862) in Spanish to find out where COVID-19 vaccines are available near you. COVID-19 vaccines are free to all people living in the United States, regardless of their immigration or health insurance status. Learn more at vaccines.gov.
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Why you should not use ivermectin to treat or prevent COVID-19
Some people are taking ivermectin, a drug often prescribed for animals, to try to prevent or treat COVID-19. FDA has not approved or authorized ivermectin for this use, and it can be dangerous for people. Information is also available in six additional languages.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 250 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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