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Cardiac Troponin T Stability Study for Regulatory Approval of the 6th Generation High-Sensitivity Assay2026 The Journal of Applied Laboratory Medicine article Medicine Acute Myocardial Infarction Research Open access
Nina M. Diederiks, Jorik H. Amesz, Fred P.H.T.M. Romijn, Enrico R. de Koning, Mark J. Boogers, Christa M Cobbaert
0citations -
Non-oncologic orphan drug approvals across the world: Types of evidence required and time to approval2025 Drug Discovery Today review Economics, Econometrics and Finance Pharmaceutical Economics and Policy Open access
Anne Pariser, Violeta V. Stoyanova-Beninska, Oxana Iliach, Reda Jundi, Kerry Jo Lee, Samantha J. Parker, +4 more
0citations -
Periodic Reassessment or Permanent Approval? A Critical Analysis of the EU Commission’s Proposal to Reform Pesticide and Biocide Authorisation in Europe2026 ChemRxiv preprint Agricultural and Biological Sciences Agricultural safety and regulations Open access
Thomas Backhaus, Nico W. van den Brink, Paul Van der Brink, Kim Oelkers, Ralf Schäfer
0citations -
The Evolution of Drug Regulatory Sciences in the Netherlands: More than a Country Report2024 Clinical Pharmacology & Therapeutics article Pharmacology, Toxicology and Pharmaceutics Pharmaceutical industry and healthcare Open access
Anna M.G. Pasmooij, Peter G. M. Mol, Jacob Cornelis Bot, Hubert G. M. Leufkens
4citations -
Gene therapy approval for Duchenne muscular dystrophy: a European perspective2025 The Lancet article Biochemistry, Genetics and Molecular Biology Virus-based gene therapy research
Hannah Jolly, Annemieke M Aartsma-Rus, Enrico Bertini, Liesbeth De Waele, Jana Haberlová, Andrea Klein, +2 more
11citations -
FDA-approved machine learning algorithms in neuroradiology: A systematic review of the current evidence for approval2023 Artificial Intelligence in Medicine review Medicine Artificial Intelligence in Healthcare and Education
Alexander G. Yearley, Caroline M.W. Goedmakers, Armon Panahi, Joanne A. Doucette, Aakanksha Rana, Kavitha Ranganathan, +1 more
21citations -
Regulatory agencies disregard real-world effectiveness evidence on product labels beyond what is reasonable2022 Journal of Clinical Epidemiology article Pharmacology, Toxicology and Pharmaceutics Pharmaceutical industry and healthcare
Rafael Dal‐Ré, Raphaël Porcher, Frits Richard Rosendaal, Brigitte Schwarzer‐Daum
0citations -
Navigating Non-interventional Post-authorization Studies in East Asia: Regulatory Challenges, Opportunities, and Future Directions2025 Drug Safety review Pharmacology, Toxicology and Pharmaceutics Pharmacovigilance and Adverse Drug Reactions Open access
Jami Peters, Ayad K. Ali, Maria Moitinho de Almeida, Keiko Asao, Tarek A. Hammad, Xintong He, +5 more
0citations -
Multiple Perspectives on the Need for Real‐World Evidence to Inform Regulatory and Health Technology Assessment Decision‐Making: Scoping Review and Stakeholder Interviews2025 Pharmacoepidemiology and Drug Safety article Economics, Econometrics and Finance Health Systems, Economic Evaluations, Quality of Life Open access
Marieke S. Jansen, Olaf M. Dekkers, Saskia le Cessie, Lotty Hooft, Helga Gardarsdóttir, Anthonius de Boer, +1 more
6citations -
Regulatory and standardization framework analysis / D1.22026 Zenodo (CERN European Organization for Nuclear Research) article Engineering Power Systems and Technologies Open access
L.R. Valencia Pérez, Alberto Dognini, Mário Couto, Efthimia Chassioti, Konstantinos F. Krommydas, Georgios A. Barzegkar‐Ntovom, +2 more
0citations -
Regulatory and standardization framework analysis / D1.22026 Zenodo (CERN European Organization for Nuclear Research) article Engineering Smart Grid Security and Resilience Open access
L.R. Valencia Pérez, Alberto Dognini, Mário Couto, Efthimia Chassioti, Konstantinos F. Krommydas, Georgios A. Barzegkar‐Ntovom, +2 more
0citations -
Periodic reassessment or permanent approval? A critical analysis of the EU Commission’s proposal to reform pesticide and biocide authorisation in Europe2026 Environmental Sciences Europe article Agricultural and Biological Sciences Agricultural safety and regulations Open access
Thomas Backhaus, Nico W. van den Brink, Paul J. Van den Brink, Kim Teppe, Ralf Bernhard Schäfer
0citations -
Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review2023 International Journal of Health Policy and Management review Health Professions Healthcare Regulation Open access
Lotje Anna Hoogervorst, Timon H. Geurkink, Anne Lübbeke, Sergio Buccheri, Jan W. Schoones, Marina Torre, +10 more
30citations -
EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells2024 British Journal of Clinical Pharmacology article Medicine Biomedical Ethics and Regulation Open access
Patrick Celis, Giada Farinelli, Ana Hidalgo‐Simon, Pauline Meij, Mara S. Tihaya, Martina Schüßler‐Lenz, +1 more
11citations