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Therapeutic Innovation & Regulatory Science|October 28, 2022
Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME DesignationsZahra Hanaizi, Sandra Kweder, Shannon Thor, et al.
Therapeutic Innovation & Regulatory Science|June 8, 2025
Strengthening the Use of International Collaborative Regulatory Assessments and Regulatory Alignment- Implications for Global ConvergenceJohn H Skerritt, Mark Mayer, Jeffrey Francer
Therapeutic Innovation & Regulatory Science|July 18, 2025
Hope is Not a Strategy: Using Robust Real-World Evidence to Make Better Clinical Development DecisionsNicolle M Gatto, Ulka B Campbell
Therapeutic Innovation & Regulatory Science|July 22, 2025
Treatment Comparison for a Single Arm Study Utilizing External Control: Performing Inference when Imputing Potential OutcomesWei-Chen Chen, Nelson Lu, Chenguang Wang, et al.
Therapeutic Innovation & Regulatory Science|July 14, 2025
Unlocking Generic Market Access: A Retrospective Analysis of USFDA Paragraph IV Filings (2020-2024)Kajal Gandhi, Ramesh Joga, M Sowndharya, et al.
Therapeutic Innovation & Regulatory Science|May 30, 2025
Diverse Roles and Characteristics of Academic Research Organizations in Japan: Results of A Questionnaire-Based StudyReo Tanoshima, Riki Tanaka, Koji Hara, et al.
Therapeutic Innovation & Regulatory Science|June 20, 2025
Tracking a Medicine's Regulatory Risk Management Commitments Provides Better Transparency and OversightSimon Ingate, Kate Bendall, Christopher Long, et al.
Therapeutic Innovation & Regulatory Science|May 24, 2025
Keeping the End in Mind: Reviewing U.S. FDA Inspections of Submissions including Real-World DataCheryl Grandinetti, Donna R Rivera, Lee Pai-Scherf, et al.
Therapeutic Innovation & Regulatory Science|May 26, 2025
The Path To Tarlatamab Approval: Leveraging Innovative Strategies and Global Regulatory PathwaysVandana Pathak, Claudia Arredondo Pimentel, Elli Cooney, et al.
Therapeutic Innovation & Regulatory Science|October 23, 2025
Risk of Venous Thromboembolism with Pemafibrate in Dyslipidemia: A Nationwide, Retrospective, Cohort Study Using a Japanese Claims DatabaseKenichiro Ikeda, Mika Tada, Shun Nakano, et al.
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