FDA’s actions in response to coronavirus disease at home and abroad

Emergency Use Authorization (EUA) Updates February 29, 2020: FDA granted an EUA to two public health laboratories in New York for a diagnostic test to identify COVID-19 (New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel). Additional technical information, including fact sheets March 2, 2020: In a joint effort, FDA and CDC took action (PDF, 129 KB) to make more respirators, including certain N95s, available to health care personnel. Currently, the majority of respirators on the market are indicated for use in industrial settings. This action allows certain National Institute for Occupational Safety and Health (NIOSH)-approved respirators not currently regulated by the FDA to be used in a health care setting by health care personnel during the coronavirus (COVID-19) outbreak, thereby maximizing the number of respirators available to meet the needs of the U.S. health care system. Also see: Coronavirus Disease 2019 (COVID-19) EUA Information

FDA Issues New Policy to Help Expedite Availability of Diagnostics On February 29, 2020, as part of FDA’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for diagnostics testing in laboratories certified to perform high complexity testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the public health emergency.  The template for these EUA submissions is available (Word doc). If you need additional information completing the template or wish to consider use of an alternative specimen type, please contact the Division of Microbiology Devices at (301) 348-1778 or email CDRH-EUA-Templates@fda.hhs.gov.

Read the FDA statement

Related link: Information for Laboratories Implementing IVD Tests Under EUA

Events New! March 4, 2020: Vaccines and Related Biological Products Advisory Committee public meeting (Silver Spring, MD and webcast) - 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 2020 to 2021 influenza season. March 5, 2020: Public workshop - Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine (Silver Spring, MD and webcast) March 5, 2020: Advancing Animal Models for Antibacterial Drug Development (Silver Spring, MD and webcast) - Hosted by FDA, the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA) to discuss progress and challenges in the development and advancement of various animal models for serious infection. New! March 12, 2020: FDA Grand Rounds - Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology  (Silver Spring, MD and webcast) March 18-19, 2020: Joint Civil & DoD CBRN Symposium (Alexandria, VA) - Hosted by the Defense Strategies Institute (fee) March 31 - April 3, 2020: Preparedness Summit (Dallas, TX) - Hosted by the National Association of County & City Health Officials (NACCHO) (fee) - FDA staff will present with other federal partners on public health preparedness and response issues including MCM emergency use and stockpiling, diagnostics, and preparedness communication. April 20-24, 2020: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories (Bethesda, MD) - Apply to attend by March 6, 2020 (deadline extended!). You can find more information about these and other events on the MCMi News and Events page.

Information for industry On March 2, 2020, FDA hosted a webinar for laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA), and others interested in learning more about this guidance. Slides are available. (PDF, 69 KB) Also see: Policy for Diagnostics Testing in Laboratories Certified to Perform High Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency Reminders for diagnostics manufacturers, from HHS: The Biomedical Advanced Research and Development Authority (BARDA), a component of the HHS Assistant Secretary of Preparedness and Response (ASPR), is supporting U.S. government market research to identify medical countermeasures with the potential to help address the 2019-nCoV outbreak. If your company is developing 2019-nCoV diagnostics, therapeutics, vaccines, or other products, submit your ideas to BARDA's online portal. HHS Seeks Abstract Submissions for 2019-nCoV Diagnostics Development - Under this EZ BAA, BARDA will review concise abstract submissions for development funding of 2019-nCoV molecular diagnostics. The diagnostics must utilize platforms already cleared by FDA, with a viable plan to meet requirements for the FDA to consider Emergency Use Authorization (EUA) within 12 weeks of an award. (February 5, 2020)

In case you missed it From NIH - The National Institutes of Health began a randomized controlled trial for the treatment of COVID-19 patients. While sponsors are usually expected to allow 30 days between submission and initiation of an initial IND protocol to allow for safety review, FDA has been using both pre-IND discussions and highly expedited initial review to allow such trials to begin as soon as possible. We continue to work with interested sponsors to help expedite any additional clinical trials for COVID-19 medical countermeasures that may be appropriate. (February 25, 2020)