Important public health and other updates from FDA since our last MCMi email include:

• Updates on Highly Pathogenic Avian Influenza (HPAI) (also see information below)
• August 16, 2024: FDA Marketing Authorization Enables Increased Access to First Step of Syphilis Diagnosis
• August 9, 2024: FDA Approves First Nasal Spray for Treatment of Anaphylaxis
• August 8, 2024: FDA released its updated 2024 Language Access Plan, taking another key step toward addressing language barriers that impact health equity and strengthening language access to health information and services for the public, including people with Limited English Proficiency and people with disabilities.
• August 7, 2024: FDA Approves First Nalmefene Hydrochloride Auto-Injector to Reverse Opioid Overdose
• July 26, 2024: FDA alerted health care providers, compounders, and patients of dosing errors associated with compounded injectable semaglutide products.
• July 22, 2024: FDA published common questions received related to laboratory developed tests (LDTs).
• Reports and papers recently issued by FDA:
• Office of Surveillance and Epidemiology 2023 Annual Report
• Discussion Paper: Health Equity For Medical Devices

More FDA press announcements

FDA released the results of the second retail sampling survey that tested dairy products for the highly pathogenic avian influenza A (H5N1). No viable virus was detected in the samples collected from retail locations and analyzed between June 18-July 31, 2024. These results strengthen previous assessments that commercial pasteurization inactivates the H5N1 virus. The USDA Agricultural Research Service and the FDA are submitting the survey results for publication in a peer-reviewed journal. The pre-publication is available at: Characterization of highly pathogenic avian influenza virus in retail dairy products in the U.S.(August 13, 2024)

In this Spotlight on CDER Science, FDA Center for Drug Evaluation and Research (CDER) reviewers combined the predictive ability of AI/ML with appropriate validation processes to develop a method to identify a patient population who will likely benefit from a drug therapy.

On November 8, 2022, FDA issued an Emergency Use Authorization (EUA) for anakinra (Kineret) for the treatment of COVID-19 in hospitalized adults with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure and likely to have an elevated plasma soluble urokinase plasminogen activator receptor (suPAR). However, an approved suPAR commercial test is not available in the U.S., which created a challenge during CDER’s review of the EUA application when identifying the patient population most likely to benefit from anakinra.

To ensure patients’ timely access to this treatment, the CDER review team used AI/ML to facilitate the identification of patients who could receive the drug under the EUA. The goal was to develop a scoring rule that would ensure a high proportion of patients meeting the criteria would have a suPAR ≥ 6 ng/mL. This was the first time that CDER used AI/ML for a regulatory decision. (July 31, 2024)

AI/ML-enabled medical devices

FDA updated the list of Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices. With this update, FDA has authorized 950 AI/ML-enabled medical devices. (August 7, 2024)

New EUA for treatment of hemorrhage or coagulopathy

FDA granted an EUA to Octapharma Pharmazeutika Produktionsges.m.b.H. for emergency use of octaplasLG Powder (blood group types A and AB) for U.S. military forces for the treatment of hemorrhage or coagulopathy during an emergency involving agents of military combat (e.g., firearms, projectiles, and explosive devices) when plasma is not available for use or when the use of plasma is not practical.
Hemorrhage, sometimes accompanied by coagulopathy (a condition that affects the blood’s ability to clot), is a leading cause of death among combat trauma casualties. Plasma contains proteins that may be effective at helping clot blood and can be used for the management of hemorrhage and coagulopathy. However, its use in combat settings is severely limited by logistical and operational challenges such as the need for refrigeration and, in the case of frozen plasma, a long thawing period.

OctaplasLG Powder is a powdered freeze-dried product that can be used following reconstitution (adding water back to the powder) in settings where refrigeration is not available, thus enabling the rapid availability of plasma for use at the point of injury. (August 8, 2024)

Recently posted information

• July 24, 2024: As part of the Guidance Snapshot PIlot program, FDA recently added resources for the 2023 final guidance, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. New resources include a snapshot about the guidance (PDF), a recap podcast (audio, 25 minutes), and a podcast transcript. 
• July 24, 2024: Final guidance: Real-World Data: Assessing Electronic Health Records and Medical Claims Data To Support Regulatory Decision-Making for Drug and Biological Products
• July 24, 2024: Final guidance: Container Closure System and Component Changes: Glass Vials and Stoppers
• July 23, 2024: Testing Human Cells, Tissues, and Cellular and Tissue-Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases (updated web page)
• July 23, 2024: Draft guidance: Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers - submit comments by September 23, 2024

Expiration date extension

You can find information about shelf-life extensions of COVID-19 vaccines, therapeutics, and in vitro diagnostic (IVD) tests, and other medical countermeasures, on our web page: Expiration Dating Extension, under MCM Expiration Dating Extensions.

Visit At-Home OTC COVID-19 Diagnostic Tests and At-Home COVID-19 Diagnostic Tests: Frequently Asked Questions for more information about expiration date extensions of at-home COVID-19 tests.

Medical Countermeasures Initiative (MCMi) Program Update report
This annual report showcases FDA's work each year to prepare for public health emergencies. Covering FY 2023, it includes updates on FDA's work agency-wide to support development of and access to medical countermeasures for a variety of public health threats.

Researching FDA
Join FDA on a journey into the heart of regulatory science, where innovation meets safety, and research drives policy decisions. At FDA, we're committed to advancing science for the benefit of society. This video series showcases our groundbreaking regulatory science work.

Q&A with FDA podcast
In this podcast series, FDA’s Division of Drug Information answers some of the most commonly asked questions received by FDA. Previous episodes include conversations about drug shortages, expanded access, avoiding medication scams, and much more.

• Check expiration date extensions for your COVID-19 tests 
• Get the latest on COVID-19 vaccines
• Know your treatment options for COVID-19