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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 approves first treatment for COVID-19
On October 22, 2020, FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care.
FDA revised the Emergency Use Authorization (EUA, PDF) for Veklury to remove those uses that are now approved under Gilead’s New Drug Application (NDA). The EUA for Veklury continues to authorize Veklury for emergency use by licensed healthcare providers for the treatment of suspected or laboratory-confirmed COVID-19 in hospitalized pediatric patients weighing 3.5 kg to less than 40 kg or hospitalized pediatric patients less than 12 years of age weighing at least 3.5 kg.
Related links:
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Emergency Use Authorization (EUA) updates
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FDA updates antigen EUA template for test developers
FDA updated the Antigen Template for Test Developers (Word doc). This template provides the FDA’s current recommendations concerning data and information that should be submitted to the FDA in support of an EUA request for a SARS-CoV-2 antigen test. This update adds recommendations regarding studies to support claims for screening asymptomatic individuals and multiplexed antigen tests. The template reflects FDA’s current thinking on the topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The FDA is open to alternative approaches. (October 26, 2020)
Diagnostic test EUAs
As of today, 285 tests are authorized by FDA under EUAs; these include 222 molecular tests, 56 antibody tests, and 7 antigen tests Also see: Coronavirus Testing Basics
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Information for industry
Developing and manufacturing drugs including biologics
- FDA consolidated existing resources for stakeholders to easily access information about drug and biologics development and manufacturing, including for products to diagnose, cure, mitigate, treat or prevent COVID-19 and for other critically needed products to treat symptoms of COVID-19 or to provide supportive care to those with COVID-19. FDA is committed towards getting medical products to market quickly and to helping ensure that these products are safe, effective and high quality. Manufacturers, applicants and sponsors, including those working under U.S. government contracts, can use these resources to find information on the applicable laws and regulations that govern drug development and manufacturing to protect the public health, including during the COVID-19 outbreak. (October 23, 2020)
FDA issues revised policy for necessary automated external defibrillator accessories
- FDA issued an immediately in effect guidance to revise its compliance policy regarding the deadline for filing premarket approval applications for previously cleared accessories that are necessary to operate automated external defibrillator (AED) systems. This policy is intended to help reduce the burden on healthcare facilities transitioning to FDA-approved AEDs and manufacturers preparing to implement the premarket approval requirements for these necessary AED accessories (such as batteries, pad electrodes, adapters, and hardware keys for pediatric use) while addressing the challenges related to COVID-19. (October 27, 2020)
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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FDA Insight podcast: Get Your Flu Vaccine
Hear from Dr. Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, why it's more important than ever to get your seasonal flu vaccine this year. (October 27, 2020)
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