Federal Institute for Drugs and Medical Devices

Recent papers from Federal Institute for Drugs and Medical Devices

1. Fall-risk in genetic variable cytochrome P450 enzymes and exposure to anticholinergic drugs – a pilot-analysis from the ADRED-studyPharmacogenomics · 2026
2. Unintentional Incorrect Route of Drug Administration: An Analysis of Spontaneous Reports of Medication Errors in Children and Adolescents from GermanyPediatric Drugs · 2026
3. EudraScore: Modification of the Vigi4Eudra-score for the Assessment of the Completeness of Adverse Drug Reaction Reports in EudraVigilanceDrug Safety · 2026
4. Application of Pharmacometric Modelling Towards Precise Dosing in Neonates, Infants and Toddlers: A Scoping ReviewClinical Pharmacokinetics · 2026
5. Toward the Use of Real‐World Data for Regulatory and HTA Decision‐Making: Experiences and Recommendations from Six EU ‐Funded ProjectsClinical Pharmacology & Therapeutics · 2026
6. The Burden of Disease of Medication Errors: Analysis in ADR Caused Emergency VisitsPharmacoepidemiology · 2026
7. Fluoroquinolone-Associated Injuries of Tendon, Muscles and Synovium: Recent Evidence From a Large German Claims Data Cohort StudyDrugs & Therapy Perspectives · 2026
8. Applicability of the ICH M7 guidelines for assessing less-than-lifetime exposure to nitrosamine impurities in drug productsRegulatory Toxicology and Pharmacology · 2026
9. Regulatory Research Priorities for AI Use in the Medicine Lifecycle: A European Perspective with Global RelevanceClinical Pharmacology & Therapeutics · 2026
10. Rare disease nomenclature and coding: challenges, systems, and policies in the global contextArchives of Medical Research · 2026
11. Patterns of Spontaneous Adverse Drug Reaction Reporting in Germany From 2012 to 2021Pharmacology Research & Perspectives · 2026
12. Therapeutic Drug Monitoring of Cannabinoids: Therapeutic Reference Ranges for Delta-9-tetrahydrocannabinol in Medical Cannabis, Nabiximols, Dronabinol and NabilonePharmacopsychiatry · 2026
13. Data Access Application Management System (DAAMS) - Technical specification for health data access bodies2026
14. Guideline for Health Data Access Bodies on data minimisation, pseudonymisation, anonymisation and synthetic data2026
15. Technical specification for Health Data Access Bodies on the implementation of secure processing environments2026
16. Considerations in Designing Clinical Trials of Novel Antibacterial Agents Using a Superiority Design.2026
17. The in vitro alkaline comet assay with liver models as a complementary tool for genotoxicity assessment of N-nitrosaminesArchives of Toxicology · 2026
18. Trends in EU regulatory assessment of oncology medicinesESMO Open · 2026
19. Guideline for data users on how to use data in a secure processing environment2025
20. Paediatric Phase I/II Clinical Trial Assessments Under the New EU Clinical Trial Regulation: A Descriptive AnalysisPharmaceutical Medicine · 2026