Latest AI and machine learning research in fda general for healthcare professionals.
Standard Automated Perimetry (SAP) is the mainstay for monitoring glaucoma progression and has been accepted by the U.S. Food and Drug Administration (FDA) as a trial endpoint, but only under stringent criteria of ≥7 dB loss in five pre-specified test locations. Identifying such locations a priori has remained a major barrier for neuroprotection trials. We developed an attention-based graph neural...
About one third of epilepsy patients are drug-resistant. Resective surgery remains a key treatment option but depends critically on accurate identification of the seizure onset zone (SOZ), which is still guided mainly by subjective visual inspection of electrophysiological signals. Network-based metrics derived from intracranial EEG (iEEG) have recently shown promise for SOZ identification, but th...
Zidovudine (AZT), a key antiretroviral drug used for HIV treatment and preventing mother-to-child transmission, has insufficient post-marketing pharma...
Predetermined Change Control Plans (PCCPs) are a recent regulatory innovation by the U.S. Food and Drug Administration (FDA) introduced to enable dyna...
Structural neuroimaging analyses require ‘research quality’ images, acquired with costly MRI acquisitions. Isotropic (3D-T1) images are desirable for ...
Development of anti-drug antibodies (ADAs) is a barrier to long-term efficacy of biologic therapies in rheumatoid arthritis (RA), but no biomarkers ex...
To identify post-marketing adverse event (AE) signals associated with isotretinoin using real-world data from the U.S. Food and Drug Administration (F...
Despite biomarker-guided treatment strategies, clinical outcomes among patients with type 2 (T2)-high asthma remain heterogeneous, with some patients ...
Information from electronic health records (EHRs) may be incorporated into computable phenotype algorithms in efforts to overcome inaccuracies of algo...
Prior research suggests that meditation may slow brain aging and reduce the risk of Alzheimer’s disease (AD). However, we lack research systematically...
Low ejection fraction (EF), an indicator of impaired heart function, often goes undiagnosed and can lead to avoidable heart failure and arrhythmias. W...
Pharmacogenomics enables personalized medicine by predicting individual drug responses based on genetic makeup, but complex guideline retrieval remain...
Overall survival (OS) remains the gold standard for oncology drug approval, but measuring it requires long follow-up and is impractical in certain onc...
Control of blood pressure (BP) continues to be a challenge globally. Clinical trials have shown home BP monitoring and text-message interventions to l...
Incomplete or incorrect causal theories are a key source of bias in machine learning (ML) algorithms. Community-engaged methodologies provide an avenu...
Clinical and population decision-making relies on the systematic evaluation of extensive regulatory evidence. The FDA drug reviews provide detailed in...
Current approaches to selecting molecularly targeted therapies (biologics and oral small molecules) for immune-mediated skin diseases largely overlook...
Intracranial pressure (ICP) monitoring is commonly used in neuro-intensive care, but its utility may be limited by a suboptimal use. The brain pressur...
Cardiovascular disease (CVD) remains a leading global health threat, responsible for one in five deaths worldwide. Early detection is critical to miti...
Ductal carcinoma in situ (DCIS) is a non-invasive breast cancer spanning a biologic continuum from atypical ductal hyperplasia (ADH) to high-grade les...