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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:
- January 5, 2021: COVID-19 Update including a warning letter and a new web page on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act)
- January 5, 2021: FDA Insight podcast: Compounded Drugs - Gail Bormel from the Office of Compliance in FDA’s Center for Drug Evaluation and Research joins Dr. Shah for a discussion on drug compounding and its contribution to fighting COVID-19.
- January 4, 2021: FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines - Until vaccine manufacturers have data and science supporting a change, we continue to strongly recommend that health care providers follow the FDA-authorized dosing schedule for each COVID-19 vaccine.
- January 4, 2021: Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19: FDA Safety Communication
- December 30, 2020: COVID-19 Update including a new communications toolkit web hub and a hand sanitizer toolkit, a year-end FDA Voices blog, two health frauds warning letters, and two ANDA approvals
Bookmark www.fda.gov/coronavirus for the latest.
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 New hand sanitizer toolkit
FDA published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. (December 30, 2020)
2020 at FDA: A year of unparalleled contributions to public health
Commissioner Stephen M. Hahn, M.D., highlights a sampling of the FDA’s achievements, many COVID-19-related, from this past year in this FDA Voices. (December 30, 2020)
Related links:
 New report: Advancing Alternative Methodologies
FDA activities to improve predictivity of human and animal response to FDA-regulated products
From FDA Chief Scientist RADM Denise Hinton, "The Advancing Alternative Methodologies report highlights the activities that FDA scientists are undertaking to foster the development of new regulatory approaches-—whether in our laboratories or through innovative collaborations with partners—that can help improve predictivity and potentially replace, reduce and/or refine animal testing." (January 5, 2021)
Read more:
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Emergency Use Authorization (EUA) updates
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Additional information about the Moderna COVID-19 vaccine
FDA posted a new web page, Moderna COVID-19 Vaccine Frequently Asked Questions. (January 5, 2021)
Risk of false results with the Curative SARS-CoV-2 test for COVID-19: FDA Safety Communication
FDA is alerting patients and health care providers of the risk of false results, particularly false negative results, with the Curative SARS-Cov-2 test. Risks to a patient of a false negative result include: delayed or lack of supportive treatment, lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community, or other unintended adverse events.
To reduce the risk of false negative results, it is important to perform the test in accordance with its authorization and as described in the authorized labeling, e.g., the Fact Sheet for Healthcare Providers (PDF). When the test is not performed in accordance with its authorization or as described in the authorized labeling, there is a greater risk that the results of the test may not be accurate. (January 4, 2021)
Diagnostic test EUAs
As of today, 310 tests and sample collection devices are authorized by FDA under EUAs. These include 235 molecular tests and sample collection devices, 64 antibody tests, and 11 antigen tests. There are 32 molecular authorizations that can be used with home-collected samples. There is 1 molecular prescription at-home test, 1 antigen prescription at-home test, and 1 over-the-counter (OTC) at-home antigen test. Also see: Coronavirus Testing Basics
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Events
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New! January 6, 2020: Virtual Town Hall Series - Coronavirus (COVID-19) Test Development and Validation, 12:15 p.m. - 1:15 p.m. ET - During the virtual town hall for SARS-CoV-2 test developers, the FDA will share information and answer your questions about the development and validation of tests for SARS-CoV-2. Registration is not required. If you are unable to attend the live virtual town hall, the recording and transcript will be available for viewing the Tuesday after the live event. FDA will host additional webinars in this series on January 13 and 27, 2021.
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January 14, 2021: CDER Compliance Conference - Participants will learn from FDA subject matter experts on a range of drug compliance topics including compounding in cleanrooms, drug importation requirements, drug supply chain security act implementation, and Risk Evaluation and Mitigation Strategies (REMS) compliance. CE credit available.
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February 2-3, 2021: Scientific and Ethical Considerations for the Inclusion of Pregnant Women in Clinical Trials (remote only) - The Duke-Margolis Center for Health Policy, under a cooperative agreement with FDA, is convening this public webinar to discuss the need for clinical research in this complex population as well as scientific and ethical considerations for the inclusion of pregnant women in clinical trials.
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New! May 26-27, 2021: Save the date! 2021 FDA Science Forum: Science as the Foundation for Protecting and Promoting Public Health (virtual) - FDA scientific experts and nationally renowned scientists will discuss eight topic areas including one on medical countermeasures, infectious disease, and pathogen reduction technologies. This year’s keynote speaker is NIAID Director Anthony Fauci, MD.
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Information for industry
CDER’s Coronavirus Aid, Relief, and Economic Security Act (CARES Act) Efforts
- The CARES Act was signed into law on March 27, 2020, to aid response efforts and ease the economic impact of COVID-19. FDA has posted a new web page listing specific authorities to enhance FDA’s ability to identify, prevent, and mitigate drug shortages under the CARES Act. (January 5, 2021)
Updated information for human cells, tissues, or cellular or tissue-based products (HCT/P) establishments regarding the COVID-19 pandemic
- COVID-19 vaccines hold the promise to alter the course of this pandemic and are complex biological products intended to be administered to millions of individuals to prevent COVID-19. Recently, vaccines for the prevention of COVID-19 have become available under emergency use authorization (EUA) issued by the FDA. Based on information available at this time, those who have received non-replicating, inactivated, or RNA-based COVID-19 vaccines are not precluded from donating HCT/Ps. Read more (January 4, 2021)
Reminder: FDA funding opportunity: FY 2021
- Extramural medical countermeasure (MCM) regulatory science is primarily funded through a Broad Agency Announcement (BAA) for research and development to support regulatory science and innovation. Proposers are encouraged to submit white papers by January 28, 2021 for FY 2021 award consideration. For more information, including examples of previously funded projects, see MCMi Extramural Research.
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 65 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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COVID-19 communication toolkits
Visit our new communication toolkits page for materials and messages from the FDA about COVID-19 to communicate with patients, the public, and health care professionals.
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