FDA authorizes a new COVID-19 treatment for certain hospitalized adults | Last chance to pre-register for data quality in BSL-4 labs course

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The latest from FDA

Public health emergency response and other updates from FDA since our last MCMi email include: April 4, 2023: FDA authorizes Gohibic (vilobelimab) injection for the treatment of COVID-19 April 4, 2023: FDA Roundup including a Spotlight on CDER Science examining pharmacodynamic biomarkers in biosimilar product development April 3, 2023: FDA Moves Forward with Mail-back Envelopes for Opioid Analgesics Dispensed in Outpatient Settings March 31, 2023: FDA Roundup including marketing authorization of a monitoring device intended to recognize and respond by a series of escalating notifications when an individual may be experiencing Opioid Induced Respiratory Depression (OIRD) due to opioid use or overdose March 31, 2023: FDA Voices: National Minority Health Month: Better Health Through Better Understanding  March 30, 2023: Health Equity Forum podcast: Advancing Health Equity with Medical Technologies (new episode) March 30, 2023: FDA Office of Minority Health and Health Equity (OMHHE) Research and Collaboration Program Featured Researcher Spotlights (two new COVID-19 research profiles) March 30, 2023: Guidance for immediate implementation: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act March 29, 2023: FDA Approves First Over-the-Counter Naloxone Nasal Spray - Also see: Access to Naloxone Can Save a Life During an Opioid Overdose Quick links: COVID-19 updates from FDA, FDA Mpox Response

COVID-19 therapeutics update

FDA authorizes Gohibic (vilobelimab) injection for treatment of COVID-19

FDA issued an EUA (PDF) for the use of Gohibic (vilobelimab) injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation (artificial life support). Also see: Frequently Asked Questions on the Emergency Use Authorization of Gohibic (PDF) (April 4, 2023)

Last chance to attend virtually

Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories April 24-28, 2023 Join FDA and the University of Texas Medical Branch for a unique opportunity for the regulatory and scientific communities to discuss complex issues in an interactive environment and identify and share best practices for ensuring data quality and integrity in maximum containment (BSL-4) facilities. FDA welcomes participants from government, industry, and academia who are working to further development of medical countermeasures for biological threat agents that must be studied in these labs. Attendance is free, but space is limited. You can still apply to attend virtually: pre-register by April 14, 2023.

Emergency Use Authorization (EUA) updates

COVID-19 in vitro diagnostic (test) EUAs As of April 4, 2023, 446 tests and sample collection devices are authorized by FDA under EUAs. These include 300 molecular tests and sample collection devices, 84 antibody and other immune response tests, 61 antigen tests, and 1 diagnostic breath test. There are 78 molecular authorizations and 1 antibody authorization that can be used with home-collected samples. There is 1 EUA for a molecular prescription at-home test, 2 EUAs for antigen prescription at-home tests, 28 EUAs for antigen over-the-counter (OTC) at-home tests, and 5 EUAs for molecular OTC at-home tests. FDA has authorized 46 antigen tests and 8 molecular tests for serial screening programs. FDA has also authorized 1,339 revisions to diagnostic EUA authorizations. Also see: COVID-19 Test Basics

Events

• New! April 13, 2023: Webinar - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence / Machine Learning-Enabled Device Software Functions Draft Guidance (1:00 - 2:30 p.m. ET) - FDA will host a webinar for medical device manufacturers and other interested stakeholders to discuss the draft guidance: Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions. The draft guidance includes proposed recommendations for the content to include in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an AI/ML-enabled device. A PCCP outlines anticipated device changes and how those changes will be assessed and implemented in accordance with the PCCP, among other things.
• April 17, 2023: Antimicrobial Drugs Advisory Committee meeting (virtual) - The committee will discuss new drug application (NDA) 216974, for sulbactam-durlobactam for injection, submitted by Entasis Therapeutics, Inc. The applicant's proposed indication is for the treatment of infections due to Acinetobacter baumannii-calcoaceticus complex including multidrug-resistant and carbapenem-resistant strains.
• April 18, 2023: Webinar on Guidances on COVID-19 Transition Plans for Medical Devices (1:00 - 2:30 p.m. ET) - FDA will host a webinar for stakeholders interested in learning more about the two final guidances on the Coronavirus Disease 2019 (COVID-19) transition plans for medical devices. 
• April 24-28, 2023: Training Course: Achieving Data Quality and Integrity in Maximum Containment Laboratories - To attend virtually, pre-register by April 14, 2023. 
• April 25, 2023: Public Meeting on Patient-Focused Drug Development for Long COVID (virtual) - This virtual public meeting will be conducted with live translation in both English and Spanish. To attend, please register.
• New! June 8, 2023: Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual) - Convened by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, to support the utilization of innovative manufacturing technologies for drugs and biological products.

Learn more about these events, and see more on the MCMi News and Events page, under Upcoming events.

Information for industry and health care providers

FDA issues guidance on cybersecurity in medical devices

FDA issued a guidance for immediate implementation: Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices Under Section 524B of the FD&C Act. FDA generally intends not to issue “refuse to accept” (RTA) decisions for premarket submissions for cyber devices that are submitted before October 1, 2023, based solely on information required by section 524B of the FD&C Act. Instead, FDA will work collaboratively with sponsors of such premarket submissions as part of the interactive and/or deficiency review process. (March 30, 2023)

FDA research examines pharmacodynamic biomarkers in biosimilar development

FDA and outside researchers have worked to identify and evaluate biomarkers in placebo-controlled studies using advanced technologies and simulations. Some of these studies were published in the January 2023 issue of Clinical Pharmacology and Therapeutics and described in this Spotlight on CDER Science, Pharmacodynamic Biomarkers: Their Role in Biosimilar Product Development. (April 3, 2023)

In March 2023, FDA issued a notice addressing the agency’s COVID-19-related guidance documents, including which of those guidance documents will no longer be in effect after the expiration of the COVID-19 public health emergency (PHE) declared under the Public Health Service (PHS) Act, and which of those guidance documents FDA is revising to temporarily continue in effect. Learn more 

In case you missed it

COVID-19 at-home tests Check the List of Authorized At-Home OTC COVID-19 Diagnostic Tests to see if the expiration date for your at-home OTC COVID-19 test has been extended. Bookmark our guide: Understanding At-Home OTC COVID-19 Antigen Diagnostic Test Results, and report your positive or negative test results at MakeMyTestCount.org.

What happens to EUAs when a public health emergency ends? There are several types of declarations and determinations related to emergencies, including public health emergencies, which serve different purposes. Learn more in this FAQ. Also see, from HHS, Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap.

Update your antibodies The virus that causes COVID-19 changes over time. Get your updated COVID-19 vaccine to help protect against COVID’s worst outcomes. Search in your zip code to find a location where a bivalent COVID-19 vaccine booster dose is available near you.

List of hand sanitizers consumers should not use Some hand sanitizers have been recalled and there are more than 380 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and use our step-by-step search guide to find out if your product is on the list.

Schedule note: This newsletter will return the week of April 17, 2023. 

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FDA Medical Countermeasures Initiative (MCMi) News)