United States Food and Drug Administration

Occurrence of Norovirus and Hepatitis A Virus RNA in Agricultural Soil from Produce Farms in Ohio and Georgia

Although foodborne viruses are considered ubiquitous in the environment, studies on their presence in soil are largely lacking. In this field study, 168 agricultural soil samples were collected from farms in Georgia and Ohio over seven and eight months, respectively. A total RNA...

Characterization of Carboxymaltose Structure and Interactions with the Iron Core in Ferric Carboxymaltose (Injectafer) Using NMR Spectroscopy

Abstract Ferric carboxymaltose (FCM), marketed as Injectafer, is an intravenous iron formulation used to treat iron deficiency. It is composed of polynuclear Fe(III)-oxyhydroxide/oxide cores surrounded by carboxymaltose. Although it has been on the market for over 10 years, the s...

Categorizing differences in postpartum hemorrhage management and associated clinical factors

Abstract Objective To examine whether there is variation in postpartum hemorrhage (PPH) management and whether differences are associated with patient‐level factors and delivery hospital. Methods This is a retrospective cohort study of patients delivered at ≥20 weeks of gestation...

Causality-integrated graph learning for multi-endpoint toxicity prediction

Toxicity prediction remains a longstanding challenge in the safety assessment of numerous artificial chemicals. While conventional single-endpoint models are effective for predicting many molecular properties, they fail to capture the complex mechanisms underlying toxicity, which...

Naloxone Distribution in the United States, 2018-2023.

. 2026;116(10):1613-1616. https://doi.org/10.2105/AJPH.2026.308541).

Validating Wing Biopsies for Blood‐Borne Pathogen Characterization in Bats

Wildlife surveillance is critical for tracking disease emergence, characterizing pathogen diversity, and assessing spillover risks. Blood-borne pathogens are of particular interest for such efforts due to their global distribution, broad host taxa, and zoonotic potential. Despite...

Quantifying and characterizing vergence-accommodation-conflict-induced cybersickness in immersive environments

Abstract A significant challenge to the widespread adoption of virtual reality (VR) and augmented reality (AR) environments is cybersickness, which affects a majority of users. With symptoms such as headache, nausea, and blurred vision, cybersickness disrupts the illusion of pres...

Efficacies of three anti-Salmonella additives - bacteriophage, formaldehyde, and formic acid - within the animal food microbiota

Abstract Bacteriophage, formaldehyde, and formic acid are anti- Salmonella additives used in animal food but their effects on its microbiota are largely unknown. We applied 16S rRNA gene amplicon sequencing and shotgun metagenomics to measure animal food microbiota shifts followi...

Sero-epidemiological survey of Toxoplasma gondii in water buffalo (Bubalus bubalis) and domestic pig (Sus scrofa domesticus) across upper and lower Egypt

Toxoplasma gondii ( T. gondii ) is a globally prevalent protozoan parasite affecting warm-blooded species, including humans. In Egypt, serological surveys have been conducted in several livestock; however, studies on species such as buffalo and pigs remain scarce. This study aime...

Analysis of Suffix Use for Biosimilar Product Identification in Postmarketing Adverse Event Reporting

Accurate identification of medicines used in adverse event reports is crucial for effective postmarketing safety surveillance. The US Food and Drug Administration's (FDA) four‐letter suffix naming convention was designed to facilitate accurate biological product identification, b...

A Multistate Investigation of Serious Adverse Events, including Deaths, following Ceftriaxone Injections, September 2024–August 2025

BACKGROUND: Reports of ceftriaxone serious adverse events (SAEs), including deaths, from multiple jurisdictions during December 2024-January 2025 prompted a nationwide investigation to evaluate product safety, characterize SAEs, and assess for changes in baseline adverse event oc...

Tracking regulatory convergence in Asia-Pacific Economic Cooperation (APEC): progress and gaps in key performance indicators

Abstract Purpose To assess progress in regulatory convergence among APEC economies using updated Key Performance Indicators (KPI) and to identify opportunities for strengthening reliance and work sharing, while informing future Phase 2 KPI development. Our work describes the adop...

A proposed evaluation of new approach methodologies for dermal toxicity assessment of botanicals

Background Botanicals are widely used in topical formulations for cosmetics, hair care, and personal care products, reflecting consumer interest in plant-derived materials. Their complex and variable composition, presents challenges for traditional toxicological approaches develo...

The INTREPID program: Linking illicit fentanyl‐containing tablets and powders seized at US borders to a common origin by combining physical/chemical identifiers and machine learning

Abstract Three US government agencies, the Drug Enforcement Administration (DEA), Customs and Border Protection (CBP), and Food and Drug Administration (FDA), established a collaborative program to leverage each agency's expertise and capabilities to characterize illicit fentanyl...

Supporting 3Rs approaches in biologicals testing: responses from a survey of Manufacturers, Contract Research Organisations, National Control Laboratories and National Regulatory Authorities

In October 2023, the UK National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs) presented recommendations to the World Health Organisation (WHO) Expert Committee for Biological Standardization following an audit of WHO vaccine and biotherapeut...

Retrospective analysis of microbial contamination in tattoo and permanent makeup inks

Abstract Microbial contamination of tattoo and permanent makeup (PMU) inks presents a persistent public health risk because these products are injected directly into the dermis. Despite regulatory oversight, outbreaks of ink-related infections continue to be reported. This study...

FDA Approval Summary: Retifanlimab for the treatment of adult patients with metastatic or inoperable locally recurrent squamous cell carcinoma of the anal canal

Abstract On May 15, 2025, the Food and Drug Administration approved retifanlimab in combination with carboplatin and paclitaxel for treating unresectable or metastatic squamous cell carcinoma of the anal canal (SCAC), and as a single agent for second-line SCAC treatment. These ap...

Examining the Validity of Message Evaluation Measures in the Context of Youth E-Cigarette Prevention

Despite the routine use of a variety of message evaluation (ME) measures (e.g., perceived message effectiveness) in formative research for tobacco education campaigns, studies assessing the validity of these measures for predicting actual message effectiveness (AME) (e.g., intent...