Center for Drug Evaluation and Research

Recent papers from Center for Drug Evaluation and Research

1. Effects of implant microstructure on drug release of ethylene vinyl acetate (EVA) based long-acting implantsDrug Delivery and Translational Research · 2026
2. A multi-platform characterization of aggregation in morpholino oligonucleotide drug products: From soluble aggregates to subvisible particles.2026
3. AI-ECG Atrial Fibrillation Detection: Unlocking Secrets in Sinus Rhythm?Circulation · 2026
4. Impact of Dosage Modifications on Efficacy: Insights from Select Tyrosine Kinase Inhibitors Approved for Treatment of Non-Small Cell Lung Cancer with EGFR MutationsClinical Cancer Research · 2026
5. Stakeholder-informed use cases and target product characteristics for vaccines and therapeutics for Nipah virus diseasenpj Vaccines · 2026
6. Torsade de pointes risk assessment categorization calculator based on an international multisite study of hiPSC-derived cardiomyocytesiScience · 2026
7. A Biopredictive Fed-State Dissolution Method Incorporating High-Viscosity Media and Hydrodynamic StressPharmaceutics · 2026
8. Biosimilar Development Considerations for Therapeutic Proteins With Limited Systemic Exposure: A Landscape Analysis and Pathway EvaluationClinical Pharmacology & Therapeutics · 2026
9. Comparing the Risk of Maternal Complications and Adverse Infant Outcomes Among Pregnancies With and Without COVID ‐19 in the Sentinel SystemPharmacoepidemiology and Drug Safety · 2026
10. Tissue-specific mutagenicity of N-nitroso-methylphenylamine assayed by the transgenic rodent assay and duplex sequencingFrontiers in Toxicology · 2026
11. Barriers and Opportunities in Therapeutic Development for Early-Onset PreeclampsiaHypertension · 2026
12. Unsupervised ensemble methods for non-wear detection from triaxial accelerometer data in children following continuous monitoringScientific Reports · 2026
13. Vitamin A levels are associated with a decrease in lymphangioleiomyomatosis progression and MITF-mediated cell growthRespiratory Research · 2026
14. Immunologic and placental responses to the VSV-EBOV vaccine in a pregnant mouse modelJCI Insight · 2026
15. Matrix tools to identify and evaluate quantitative bias analysis methods for summary-level epidemiologic dataBMC Medical Research Methodology · 2026
16. Landscape Analysis of Digital Health Technology Use for Remote Data Acquisition in CDER ‐Regulated Submissions, 2023–2025Clinical and Translational Science · 2026
17. Tecovirimat and the Treatment of Monkeypox — Past, Present, and Future ConsiderationsNew England Journal of Medicine · 2022
18. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control studyThe Lancet · 2013
19. Food and Drug Administration's Obesity Drug Guidance DocumentCirculation · 2012
20. Notes from the Field: Investigation of Unapproved Botulinum Toxin Product Administered at a Medical Spa — Colorado, 2025–2026MMWR Morbidity and Mortality Weekly Report · 2026