COVID-19 updates from FDA | Antimicrobial resistance paper & public meeting

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Coronavirus Disease 2019 (COVID-19) updates

Actions by the FDA in our ongoing response to the COVID-19 pandemic since our last MCMi email update include: October 13, 2020: Daily roundup on new guidance regarding molecular influenza and RSV tests October 7, 2020: FDA Issues Warning Letter to Battelle Memorial Institute, a Manufacturer of an Authorized Decontamination System Used on Respirators Bookmark www.fda.gov/coronavirus for the latest.

Antimicrobial resistance update

Potential approach for ranking of antimicrobial drugs according to their importance in human medicine FDA released a concept paper, Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs, for public comment and announced a virtual public meeting on November 16, 2020. Register by November 12, 2020. Also see: Antimicrobial Resistance Information from FDA (October 9, 2020)

Emergency Use Authorization (EUA) updates

New Q&A from CDRH:  Q: What are FDA's priorities with respect to review of EUA requests for COVID-19 tests? A: We are currently in a different phase of the pandemic with respect to tests than we were previously, where many COVID-19 tests are now authorized to be run in labs. We prioritize review of EUA requests for tests taking into account a variety of factors, including those discussed in the Emergency Use Authorization of Medical Products and Related Authorities Guidance, such as the public health need for the product and the availability of the product. We have, for example, prioritized review of EUA requests for tests where authorization would increase testing accessibility (e.g., point of care (POC) tests, home collection tests, at-home tests) or would significantly increase testing capacity (e.g., tests that reduce reliance on test supplies, high-throughput, widely distributed tests). In light of this and the recent HHS announcement that FDA will not require premarket review of LDTs, to make the best use of our resources for the greatest public health benefit, FDA is declining to review EUA requests for LDTs at this time. FDA continues to prioritize review of EUA requests for POC tests, home collection tests, at-home tests, tests that reduce reliance on test supplies, and high-throughput, widely distributed tests. (October 7, 2020)  Also see: FAQs on Testing for SARS-CoV-2 Warning letter FDA issued a warning letter to Battelle Memorial Institute for failure to comply with regulatory reporting requirements. The Battelle Memorial Institute’s Critical Care Decontamination System is authorized under an EUA for decontaminating certain filtering facepiece respirators (FFRs) for reuse by health care personnel when there are insufficient supplies of FFRs due to the COVID-19 pandemic. Based on the conditions of the EUA, Battelle Memorial Institute must have Medical Device Reports (MDRs) reporting processes in place as specified in the EUA and the FDA has determined they do not. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. The FDA has an ongoing commitment to evaluate devices authorized for emergency use, to ensure compliance with conditions, and that the devices remain appropriate for authorization. Read more in the FDA news release (October 7, 2020) Diagnostic test EUAs As of today, 279 tests are authorized by FDA under EUAs; these include 217 molecular tests, 56 antibody tests, and 6 antigen tests Also see: Coronavirus Testing Basics

Events

• Today! October 14, 2020: Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests - FDA will host a virtual Town Hall for SARS-CoV-2 test developers, 12:15 p.m. - 1:15 p.m. ET. The purpose of this Town Hall is to help answer technical questions about the development and validation of tests for SARS-CoV-2. FDA will host additional town halls in this series on Wednesdays in October. To ensure you are connected, please dial-in at 12:00 p.m. ET
• October 22, 2020: Vaccines and Related Biological Products Advisory Committee (webcast) - The committee will meet to discuss, in general, the development, authorization, and/or licensure of vaccines to prevent COVID-19. No specific application will be discussed at this meeting. Event materials
• October 22-23, 2020: FDA Public Workshop: Pediatric Dose Selection (virtual) - FDA, in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), will host a two-day virtual public workshop to discuss the present state of dose selection and how it pertains to pediatric drug development. This workshop is intended for clinicians, drug developers, and regulators. Pre-registration is required. 
• October 27, 2020: Save the date for the next event in FDA's webinar series to share information and answer your questions on respirators and other personal protective equipment (PPE). Printable slides and transcripts from previous events in this series are available. 

Information for industry

Medical devices

• New Q&A from CDRH: Q: How should I evaluate my 3D printed swab?
  A: As a general matter, 3D printing can introduce certain challenges not seen with conventional manufacturing. FDA is aware that some users have reported concerns of brittle 3D printed swabs that have broken into multiple sharp pieces, and non-traditional capture geometries that may not capture the sample sufficiently. While FDA and the clinical community have vast experience with traditional swabs, there is limited prior experience with the use of 3D printed swabs for specimen collection for diagnostic testing. Therefore, it is important that 3D printed swabs be assessed to ensure they are appropriately characterized for the end use to determine if they meet the clinical need. Read the full answer (October 7, 2020) - Also see: 3D Printing in FDA’s Rapid Response to COVID-19  
• FDA issued a letter to health care providers recommending that health care providers give clear, step-by-step instructions to patients who, in a health care setting, are self-collecting anterior nasal samples for SARS-CoV-2 testing. Without proper instructions, patients may not collect an adequate sample for testing, which may decrease the sensitivity of the test. (October 7, 2020)  

Drugs

• FDA updated the Coronavirus Treatment Acceleration Program (CTAP) dashboard. As of September 30, 2020, 550+ drug development programs were in planning stages, 350+ trials were reviewed by FDA and 5 COVID-19 treatments were currently authorized for emergency use. 

The 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.

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

It’s a good time to get your flu vaccine Haven’t had your flu shot yet? It’s not too late. And there are still good reasons to get one.

COVID-19 resources for health professionals Find information about medical products FDA has authorized for emergency use, frequently asked questions about personal protective equipment (PPE), a Patient Outreach Toolkit, and more.

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FDA Medical Countermeasures Initiative (MCMi) News)