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Therapeutic Innovation & Regulatory Science|July 15, 2026
Methods for Assessing Therapeutic Innovation of Drugs: Changes at the Italian Medicine AgencyDomenico Motola, Nicola Montanaro, Massimiliano Broccoli, et al.
Therapeutic Innovation & Regulatory Science|September 18, 2018
How the Critical Path Initiative Addresses CDER's Regulatory Science Needs: Some Illustrative ExamplesMark Geanacopoulos, Ruth Barratt
Therapeutic Innovation & Regulatory Science|September 20, 2018
Cycle Time Metrics for Multisite Clinical Trials in the United StatesDiana Abbott, Robert Califf, Briggs W Morrison, et al.
Therapeutic Innovation & Regulatory Science|September 18, 2018
Pre-Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic ProductsHong H Vu, Anne R Pariser
Therapeutic Innovation & Regulatory Science|July 17, 2026
Analysis of Serious Breach Cases Reported in the EU Clinical Trials Information System: Quantitative and Qualitative AssessmentEwelina Wodnicka, Damian Swieczkowski
Therapeutic Innovation & Regulatory Science|July 30, 2026
Effects of Generic Prednisolone Formulations on the Dissolution Behavior of Mycophenolate Mofetil under Various pH ConditionsRyuto Ohashi, Nao Shinotsuka, Shoya Yoshida, et al.
Therapeutic Innovation & Regulatory Science|August 8, 2026
Psychotropic Drug Scheduling and Benzodiazepine Receptor Agonist Prescribing in Japan: An Interrupted Time Series AnalysisKota Tatsuoka, Shota Hamada, Sayuri Shimizu, et al.
Therapeutic Innovation & Regulatory Science|July 17, 2026
35 Years of GLP in Germany: A Brief Overview About Its Successful HistorySebastian Schmidtsdorff, Christian Strüh
Therapeutic Innovation & Regulatory Science|July 29, 2026
Regulatory Alignment on Surrogate Endpoints for Slowly Progressive Ultra-Rare Neurological Diseases: Bridging the Gap Between Biomarker Science and Global Regulatory AcceptanceShihshuan Fang, Shenghan Chen
Therapeutic Innovation & Regulatory Science|September 10, 2026
Contribution of Real-World Evidence for the Orphan Medicines Approvals in the European Union Between 2000 and 2025Luísa Bouwman, Diogo Almeida, Carla Jonker, et al.
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