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The latest from FDA
Public health emergency response and other updates from FDA since our last MCMi email include:
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Updates on Highly Pathogenic Avian Influenza (HPAI) (also see information below)
- April 29, 2024: FDA to Hold Listening Session as Part of Broader Work to Optimize Use of, and Processes for, Advisory Committees
- April 29, 2024: FDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed Tests (also see Information for industry and health care providers below)
- April 26, 2024: FDA Voices: A Milestone in Facilitating the Development of Safe and Effective Biosimilars
- April 23, 2024: FDA Launches Health Care at Home Initiative to Help Advance Health Equity
- April 22, 2024: FDA Safety Communication: FDA Encourages the Public to Follow Established Choking Rescue Protocols
- April 17, 2024: FDA's Center for Devices and Radiological Health (CDRH) released two companion reports on medical device safety and innovation (PDFs).
- April 16, 2024: The White House released the 2024 U.S. Global Health Security Strategy (PDF), to protect the health, lives, and economic well-being of the American people and people throughout the world.
- April 16, 2024: Counterfeit Version of Botox Found in Multiple States
- April 16, 2024: CDRH unveiled a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.
- April 15, 2024: FDA's Center for Drug Evaluation and Research (CDER) announced the launch of the CDER Center for Clinical Trial Innovation (C3TI).
- April 15, 2024: FDA announced a funding opportunity for meetings on medical policy activities.
- April 11, 2024: FDA posted a new Drug Trials Snapshot for Paxlovid, a prescription medicine that is used to treat mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
- April 3, 2024: FDA Approves New Antibiotic for Three Different Uses (also see Antimicrobial resistance update below)
- April 3, 2024: The Office of Pharmaceutical Quality (OPQ) in FDA’s Center for Drug Evaluation and Research (CDER) published its 2023 Annual Report (PDF).
- April 2, 2024: CDER Conversation: Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data
- April 2, 2024: Consumer Update: Is Food Safe if it Has Chemicals?
More FDA press announcements
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HPAI response updates
Highly pathogenic avian influenza (H5N1) in dairy cows
Highly pathogenic avian influenza (HPAI) is a disease that is highly contagious and often deadly in poultry, caused by highly pathogenic avian influenza A (H5) and A (H7) viruses; it is also known as bird or avian flu. HPAI viruses can be transmitted by wild birds to domestic poultry and other bird and animal species. Although bird flu viruses do not normally infect humans, sporadic human infections have occurred. It is important to note that “highly pathogenic” refers to severe impact in birds, not necessarily in humans.
The U.S. Department of Agriculture (USDA), FDA, and the Centers for Disease Control and Prevention (CDC), along with state partners, continue to investigate an outbreak of HPAI virus impacting dairy cows in multiple states. Infection with the virus is causing decreased lactation, low appetite, and other symptoms in affected cattle.
On May 1, 2024, FDA announced an additional set of results from our national commercial milk sampling study underway in coordination with USDA. The study includes 297 total retail dairy samples. New preliminary results of egg inoculation tests on a second set of 201 quantitative polymerase chain reaction (qPCR)-positive retail dairy samples, including cottage cheese and sour cream, in addition to fluid milk, show that pasteurization is effective in inactivating HPAI. This additional preliminary testing did not detect any live, infectious virus. In addition to preliminary results released late last week on an initial set of 96 retail milk samples, these results reaffirm our assessment that the commercial milk supply is safe.
FDA continues to advise strongly against the consumption of raw milk and recommends that industry does not manufacture or sell raw milk or raw milk products.
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Learn more from FDA and our federal partners:
Consumer information on milk safety from FDA:
Artificial intelligence update
New software to identify patients at risk for sepsis
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FDA granted authorization for Prenosis, Inc.’s Sepsis ImmunoScore, an Artificial Intelligence/Machine Learning-Based Software that identifies patients at risk for having or developing sepsis. Each year, according to the Centers for Disease Control and Prevention, at least 1.7 million adults in the U.S. develop sepsis, and nearly 270,000 die as a result.
The device uses data from the patient's electronic health record in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment for presence of or progression to sepsis within 24 hours of assessing a patient who has been admitted to the emergency department or hospital and meets certain other criteria. It should not be used as the sole basis to determine the presence of sepsis. (April 2, 2024)
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Related links
Antimicrobial resistance updates
FDA approves new antibiotic for three different uses
FDA approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP).
“The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Zevtera will provide an additional treatment option for a number of serious bacterial infections,” said Peter Kim, M.D., M.S., director of the Division of Anti-Infectives in FDA’s CDER. “The FDA will continue our important work in this area as part of our efforts to protect the public health.” (April 3, 2024)
FDA approves new antimicrobial drug for cattle and swine
FDA approved Pradalex (pradofloxacin injection) solution for certain respiratory diseases in cattle and swine. Pradofloxacin is a medically important antimicrobial in the fluoroquinolone class and may only be prescribed by a licensed veterinarian as a single injection.
Over the past several decades, FDA has implemented policies to help ensure that medically important antimicrobials approved for use in animals are used in a manner that is consistent with principles of antimicrobial stewardship. For example, all medically important antimicrobials for animals require the authorization of a licensed veterinarian because FDA believes that, given their specialized training and experience, veterinarians play a critical role in antimicrobial stewardship and can help reduce the risks of antimicrobial resistance. (April 9, 2024)
FDA approves new treatment for uncomplicated urinary tract infections
FDA approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. (April 24, 2024)
BioMérieux Inc. recalls VITEK 2 AST Kit
BioMérieux is recalling VITEK 2 AST cards, an antimicrobial sensitivity testing (AST) kit, due to a higher concentration of ceftriaxone antibiotic in two wells. This kit is used for testing how sensitive bacteria are to antibiotics. (April 30, 2024)
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Emergency Use Authorization (EUA) updates
New at-home tests to detect COVID-19 and flu
On April 3 and April 5, 2024, respectively, FDA issued an EUA for OSANG LLC’s QuickFinder COVID-19/Flu Antigen Self Test and CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test. Both are single use tests intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests.
Validation data to support the EUA of both tests was gathered through the National Institutes of Health (NIH) Independent Test Assessment Program (ITAP), established as a collaboration between the FDA and the NIH. The tests can be used for people aged 14 years or older with a self-collected nasal swab specimens and aged 2 years or older when an adult collects the nasal swab specimens.
EUA revocations
FDA revoked the following EUAs for the reasons noted in the revocation letters (PDFs):
EUA quick links
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 Events
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May 2-3, 2024: Considerations and Potential Regulatory Applications for a Model Master File (Rockville, MD or virtual), hosted by FDA and the Center for Research on Complex Generics
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May 9, 2024: Public Workshop: In-person and Hybrid How Much is Enough? Trial Designs for Treatment Regimens with Multiple Phases (virtual)
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May 9, 2024: Blood Products Advisory Committee (virtual) - The committee will meet in open session to discuss strategies to reduce the risk of transfusion-transmitted malaria by testing blood donations from donors at risk of malaria exposure
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May 13, 2024: Natural History Studies and Registries in the Development of Rare Disease Treatments (Silver Spring, MD or virtual) - To attend, please register.
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May 14, 2024: Webinar - Final Rule: Medical Devices; Laboratory Developed Tests - All questions must be received by May 7, 2024, to be considered for the discussion.
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May 16, 2024: Statistical Considerations for Premarketing Risk Assessment (virtual)
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May 16, 2024: Vaccines and Related Biological Products Advisory Committee (virtual) - The committee will meet in open session to discuss and make recommendations on the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.
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May 29-30, 2024: Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development, with tracks for drugs, devices and biologics (College Park, MD or virtual)
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June 13, 2024: Public Meeting: Optimizing FDA’s Use of and Processes for Advisory Committees (virtual listening session) Also see: Advisory Committees Give FDA Critical Advice and the Public a Voice
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July 30 - August 1, 2024: Training Course: Achieving Data Quality and Integrity in Clinical Trials Involving High-Consequence Pathogens (Omaha, Nebraska or virtual) - Save the date, and pre-register by June 30, 2024 to attend in-person, or by July 12, 2024 to attend virtually.
More events: FDA Meetings, Conferences and Workshops
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Information for industry and health care providers
Guidance and updates for industry
LDTs: On April 29, 2024, FDA took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years. LDTs are in vitro diagnostic products (IVDs) that FDA has described as intended for clinical use and designed, manufactured and used within a single clinical laboratory that meets certain regulatory requirements. FDA announced a final rule amending FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. Along with this amendment, FDA issued a policy to phase out, over the course of four years, its general enforcement discretion approach for LDTs. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories. On May 14, 2024, FDA will host a webinar to provide an overview of the final rule and phaseout policy. Also see: Laboratory Developed Tests: Frequently Asked Questions |
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CDRH also issued two draft guidances on April 29, 2024. Submit comments on both by July 5, 2024.
FDA's Center for Biologics Evaluation and Research (CBER) issued two draft guidances on April 30, 2024. Submit comments on both by July 29, 2024.
Comment deadline reminders for draft guidances issued in March 2024
Expiration date extension
Did you know? 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.
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In case you missed it
Quick COVID-19 resources
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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.
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List of hand sanitizers consumers should not use
Some hand sanitizers have been recalled and there are more than 650 hand sanitizers the FDA recommends you stop using right away. Bookmark www.fda.gov/handsanitizerlist for the latest, and learn more about safely using hand sanitizer.
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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.
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