FDA General

Using Artificial Intelligence to Identify Patterns and Predictors of Adverse Drug Reactions in Cardiovascular Patients: A Comprehensive Narrative Review.

Artificial intelligence (AI) has emerged as a transformative tool for improving the detection, prediction, and prevention of adverse drug reactions (ADRs) in cardiovascular (CV) medicine, a domain characterized by high drug utilization, complex multimorbidity, and substantial polypharmacy. Traditional pharmacovigilance (PV) systems, particularly spontaneous reporting, remain limited by underreport...

Wiz regulates clustered protocadherin genes by restricting CTCF/cohesin loop extrusion in a genomic-distance biased manner.

Zinc finger proteins (ZFPs or ZNFs) constitute the largest family of transcription factors in mammals; however, their regulatory mechanism remains largely elusive. Here we propose COP (C2H2-ZFP occupancy predictor), a deep learning-based heuristic screening tool that integrates DNA sequence with protein primary and secondary features to assess ZFP genomic enrichments. Applying COP to the mouse clu...

Personalised approach to hypertension treatment: protocol for the HYPERMARKER randomised controlled trial.

INTRODUCTION: Blood pressure treatment response is variable in individual patients, and the choice of medical therapy is often dependent on clinician ...

Awareness, knowledge and attitudes towards artificial intelligence among nursing students: a systematic review protocol.

INTRODUCTION: Internationally, nursing students' awareness and familiarity with artificial intelligence (AI) remain a challenge as evidenced by the cu...

Genome-wide characterization highlights the regulatory network rewiring of BTB genes in barley under stress condition.

UNLABELLED: The Bric-a-Brac/Tramtrack/Broad Complex (BTB) gene family plays an important role in plant stress responses, gene regulation, and function...

Occupational therapists' use of digital technologies to support people with disabilities in engaging in occupation: a scoping review protocol.

INTRODUCTION: Digital tools such as virtual reality, mobile applications and digital devices are being implemented across various healthcare practice ...

Development of a predictive marker panel for the individualised bDMARD therapy of psoriatic arthritis: protocol for a prospective observational study (Integrate-PsA).

INTRODUCTION: Psoriatic arthritis is a chronic inflammatory disease that can affect the axial skeleton as well as the joints and enthesis. Following t...

Assessing the readability of AI-generated medication counseling for common Medicaid drug classes: metformin, lisinopril, and atorvastatin.

BACKGROUND: Metformin, lisinopril, and atorvastatin rank among the most commonly prescribed medications for Medicaid patients; however, patients often...

Insecticide Resistance Beyond Genetics: Integrating Microbiomes, Machine Learning, and Emerging Molecular Technologies.

Insecticide resistance has become a serious and escalating threat to global agriculture, undermining food security, farmer livelihood, and environment...

An encyclopedia of human enhancer-gene regulatory interactions.

Identifying transcriptional enhancers and their target genes is essential for understanding gene regulation and the effect of human genetic variation ...

GATESynergy: Integrating Molecular Global-Local Aggregator and Hierarchical Gene-Gated Encoder for Drug Synergy Prediction.

Combination drug therapy is an effective approach to combating drug resistance and enhancing therapeutic efficacy in complex diseases such as cancer. ...

Scientific evidence of commercial artificial intelligence products for pulmonary nodule assessment on CT scans: a systematic review.

OBJECTIVES: This systematic review evaluates the available evidence on the efficacy of commercially available AI-software applications for lung nodule...

Integrating human and artificial intelligence for robust postmarketing safety surveillance systems: reflections from the FDA Sentinel Innovation Center.

OBJECTIVES: To describe considerations for integration of human and artificial intelligence for creating a postmarketing surveillance system capable o...

Infection risk in rheumatoid arthritis patients treated with biologic and targeted synthetic DMARDs: prediction models and use of machine learning.

Infection risk is an important consideration during treatment decision-making in rheumatoid arthritis (RA), including at the initiation of biologics o...

Artificial Intelligence-Based Computer-Aided Detection in Breast Cancer Diagnosis: Variation by Breast Density, Imaging Feature, and Tumor Characteristics.

RATIONALE AND OBJECTIVES: To determine whether an FDA-approved artificial intelligence computer-aided detection and diagnosis (AI-CAD) system assigns ...

Microfluidic-enabled stretchable thermoelectric device array for multimodal haptic interfaces.

Stretchable thermoelectric devices hold significant promise for thermal haptic interfaces. However, their development has been constrained by limited ...

Multi-omics fusion with machine learning enables robust prediction of treatment response in ovarian cancer for precision population health.

Inter-patient heterogeneity complicates predicting treatment response in ovarian cancer (OC). We developed OMICS-FUSE, an early-fusion multi-omics pre...

Medical Affairs in the Age of Complexity: From Scientific Support to Strategic Enterprise Integrator.

Regulatory acceleration, expanded reliance on real-world evidence (RWE), and increasing integration of artificial intelligence (AI) into healthcare sy...

How Digital Health Technologies have been Used to Support Regulatory Drug Approval.

OBJECTIVE: The integration of Digital Health Technologies (DHTs) in clinical trials enhances patient recruitment, streamlines data collection, and pro...

Disease-modifying antirheumatic drugs (DMARDs) for rheumatoid arthritis after failure of biologic or targeted synthetic therapy: a systematic review and network meta-analysis.

RATIONALE: After inadequate response to first-line biologic or targeted synthetic (b/ts) disease-modifying antirheumatic drug (DMARD) therapy in adult...