United States Food and Drug Administration

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...