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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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Note: Some items noted herein were prepared prior to the change in Administration and may reference Stephen Hahn, M.D., Commissioner of Food and Drugs, Food and Drug Administration (FDA). Janet Woodcock, M.D., was named Acting Commissioner of Food and Drugs, FDA on January 20, 2021.
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 Accelerating the adoption of advanced manufacturing technologies to strengthen our public health infrastructure
Remember in-person meetings? A year ago, would you have thought our world, our homes and offices would be upended and changed so rapidly? Seemingly overnight businesses were adapting to a new reality. We at FDA adapted as well – we had to. Our mission is so critical, we couldn’t fall behind because too much was, and still is, at risk. At the start of this 21st year of the 21st Century, businesses, manufacturers, the FDA, and patients, are all adjusting to the changing times and adopting new trends. For the day-to-day work of the FDA those changes are focused on advanced manufacturing technologies, digital industry and “Industry 4.0."
FDA is creating a new collaboration with the National Institute of Standards and Technology (NIST) through a memorandum of understanding (MOU). This MOU is intended to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products and medical devices through adoption of 21st century manufacturing technologies.
Related links:
Emerging SARS-CoV-2 variants
FDA continues to closely monitor the various identified variants of the virus that causes COVID-19 circulating globally, as well as monitoring for emerging variants. We will continue to factor in newly emerging information in light of our role in regulating diagnostics, therapeutics and vaccines to fight COVID-19.
We are assessing the impact of the new strains on authorized products and are working with medical product sponsors to provide information on evaluating any potential impact that these or other variants may have on effectiveness of their products. At this time, available information suggests that currently authorized vaccines remain effective in protecting the American public against current strains of COVID-19.
FDA has already given thought to developing a potential pathway, should changes need to be made to authorized COVID-19 vaccines or other products based on information on emerging variants. We are committed to having a public and transparent process around our path forward. The agency has experience with other situations where such changes are needed, for example, as is the case with influenza virus vaccines.
FDA is planning for all scenarios to ensure that we address any impacts to products as quickly as possible. (January 25, 2021 statement from Dr. Janet Woodcock)
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Emergency Use Authorization (EUA) updates
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Updated recommendations for investigational COVID-19 convalescent plasma
FDA updated its Investigational COVID-19 Convalescent Plasma guidance and corresponding web page. The revisions provide recommendations regarding when individuals who have received an investigational COVID-19 vaccine as a participant in a clinical trial, or received an authorized or licensed COVID-19 vaccine, qualify as convalescent plasma donors. In addition, the agency has extended the period of enforcement discretion described in the guidance. (January 15, 2021)
Decontamination system EUA updates
FDA reissued EUAs for 10 decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there is an insufficient supply of new respirators resulting from the COVID-19 pandemic. Among other things, the reissued EUAs for certain decontamination systems are now only authorized to decontaminate each compatible N95 respirator a maximum of four or fewer times. Also see the new web page: FAQs for Filtering Facepiece Respirator (FFR) Decontamination Systems (January 22, 2021)
Diagnostic test EUAs
As of today, 320 tests and sample collection devices are authorized by FDA under EUAs. These include 238 molecular tests and sample collection devices, 69 antibody tests, and 13 antigen tests. There are 33 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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Today! January 27, 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 February 3, 10, 17, and 24, 2021.
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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! February 23, 2021: Save the date for the next webinar in the 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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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
Guidance documents
- To help protect consumers from methanol poisoning, FDA issued a new guidance, Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (COVID-19), to notify drug manufacturers and compounders of FDA’s policy on certain testing procedures on all lots of alcohol and isopropyl alcohol prior to manufacturing to prevent methanol contamination or substitution in drugs. Methanol is not an acceptable ingredient for any drug product and should not be used due to its toxic effects. (January 19, 2021)
- FDA posted updated information for blood establishments regarding the COVID-19 pandemic and blood donation. (January 19, 2021)
- FDA issued and immediately implemented a new guidance, Protecting Participants in Bioequivalence Studies for Abbreviated New Drug Applications During the COVID-19 Public Health Emergency. This guidance assists prospective applicants of abbreviated new drug applications (ANDAs) on ensuring participants are protected when resuming or initiating bioequivalence studies conducted to support the approval of an ANDA that has been disrupted during the COVID-19 public health emergency. (January 15, 2021)
- FDA issued and immediately implemented a new guidance, Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. Hypercoagubility has been observed in patients with COVID-19. The guidance is intended to foster the continued availability of safe and effective medical devices while being flexible regarding certain modifications made to coagulation systems for measurement of whole blood viscoelastic properties to include use in hospital patient healthcare settings in response to the COVID-19 public health emergency. (January 14, 2021)
- FDA issued a temporary guidance, COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity. This guidance describes methods that applicants should use to ensure the potency of monoclonal antibodies and other therapeutic proteins proposed for use as anti-infective agents for COVID-19. The FDA issued this guidance to help development of monoclonal antibodies and other therapeutic proteins for use as COVID-19 therapeutics. (January 13, 2021)
Last chance! 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 70 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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