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Coronavirus Disease 2019 (COVID-19) updates
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Actions by 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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FDA authorizes first COVID-19 test for self-testing at home
On November 17, 2020, FDA issued an EUA to Lucira Health for its COVID-19 All-In-One Test Kit for prescription home use. The Lucira Health COVID-19 All-In-One Test Kit:
- Is authorized for use at home in individuals age 14 and older who are suspected of having COVID-19 by their healthcare provider.
- Is also authorized for use in places such as doctors’ offices, urgent care settings, and hospitals (known as point of care settings) in individuals of all ages, but individuals age 13 and under must have their sample collected by a healthcare provider at the point of care.
- Is a molecular, single-use test that can detect SARS-CoV-2, the virus that causes COVID-19.
- Provides results using a light-up display in 11-30 minutes.
Related links:
A closer look at COVID-19 diagnostic testing
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The FDA has been working around the clock to help increase the availability of critical medical products, including diagnostic tests, to fight the COVID-19 pandemic.
A patient and consumer overview of COVID-19 testing has plain language information about both diagnostic and antibody testing for COVID-19. This new companion resource takes a closer look at diagnostic testing for COVID-19 and may be of interest to health care providers, test purchasers, and other public health professionals. (November 16, 2020)
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Emergency Use Authorization (EUA) updates
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FDA's ongoing commitment to transparency for COVID-19 EUAs
Statement from FDA Commissioner Stephen M. Hahn, M.D.
"EUAs are an important tool in our country’s fight against COVID-19 and other public health emergencies. While EUAs have received increased attention during the COVID-19 public health emergency, EUAs are not a new tool to the FDA. I want to take a moment to reaffirm FDA’s commitment to transparency around the EUA process and share some updates on our plan to provide more information about FDA’s decisions to issue, revise, or revoke EUAs for drugs and biological products, including vaccines.
"I am announcing today that our drug and biological product centers intend, to the extent appropriate and permitted by law, to publicly post their reviews of the scientific data and information supporting the issuance, revision, or revocation of EUAs for all drug and biological products, including vaccines, as part of our COVID-19 response." Read the full statement (November 17, 2020)
FAQs on testing for SARS-CoV-2
This week, FDA reorganized the FAQs on Testing for SARS-CoV-2 page to make it easier to navigate to questions by topic, and updated the answers to certain questions in the sections:
Diagnostic test EUAs
As of today, 289 tests are authorized by FDA under EUAs; these include 224 molecular tests, 58 antibody tests, and 7 antigen tests Also see: Coronavirus Testing Basics
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Events
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Today! November 18, 2020: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation - FDA will host a virtual Town Hall for SARS-CoV-2 test developers, 12:15 p.m. - 1:15 p.m. ET. To ensure you are connected, please dial-in at 12:00 p.m. ET. Additional webinars in this series will be held in 2020 on December 2, 9, and 16.
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December 4, 2020: SEND for CBER, What You Need to Know webinar, 1:00 - 2:00 p.m. ET, to discuss Center for Biologics Evaluation and Research’s (CBER’s) support and requirement for the Standard for the Exchange of Nonclinical Data (SEND), which was published in the Federal Register on July 14, 2020, and the addition of SEND for CBER to the FDA Data Standards Catalog. Please register in advance.
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December 8, 2020: Webinar Series - Respirators and Other Personal Protective Equipment (PPE) for Health Care Personnel Use During the COVID-19 Pandemic, 12:00 - 1:00 p.m. ET
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New! December 16, 2020: Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA - webinar, 1:00 - 2:30 p.m. ET - Also see: Drug Trials Snapshots, including a new 2015-2019 Drug Trials Snapshots Summary Report (PDF)
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Information for industry
Request for input from the additive manufacturing community
- FDA has initiated a study to summarize the impact of non-traditional and community responders using 3D-printing in addressing supply shortages and gaps in medical supplies. The U.S. public health, safety and security will benefit from identifying the best practices and lessons learned from the COVID-19 response. If you are affiliated with a health care provider or are a community responder and would like to contribute to the study, please go to the America Makes website. (November 13, 2020)
Investigational COVID-19 Convalescent Plasma update
- FDA updated its guidance on investigational COVID-19 convalescent plasma. The updated guidance extends the period of enforcement discretion through the end of February 2021. This extension will allow continued access to convalescent plasma for the treatment of hospitalized COVID-19 patients while blood establishments develop the necessary operating procedures to manufacture COVID-19 convalescent plasma consistent with the EUA. The guidance also includes a new recommendation that authorized COVID-19 convalescent plasma not be collected from individuals who have received an investigational COVID-19 vaccine. (November 16, 2020)
COVID-19 At-Anywhere Diagnostics Design-A-Thon launched
Join us in developing technical innovations to help fight COVID-19! The COVID-19 At-Anywhere Diagnostics Design-a-Thon is a virtual technology sprint using HealthData.gov COVID-19 Innovation and open data to:
- Improve speed, utility, and comprehensiveness of diagnostic data collection and use
- Develop user-friendly, integrated software and digital health tools to overcome the challenges of at-anywhere testing
- Facilitate the capture, harmonization, and secure transmission of key data elements to public health authorities, healthcare providers, and patients.
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 60 COVID-19-related guidances to date.
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In case you missed it
COVID-19 Vaccines
FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. Get the latest: www.fda.gov/covid19vaccines
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 200 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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