1. Using Bayesian Dynamic Borrowing to Maximize the Use of Existing Data: A Case-Study

   • Dawn Edwards
   • N. Best
   • A. Fowler

   Analytical Report Open access 01 November 2023 Pages: 1 - 10

   

2. Evaluation of a Pilot: Inspection Facilitation and Collaboration Using a Mixed Reality Device

   • Peter Baker
   • Tamika Cathey
   • Jared R. Auclair

   Analytical Report Open access 22 November 2023 Pages: 11 - 15

3. The Term ‘Deselect’ is Ambiguous as Used in Research Studies to Support Prescription to Nonprescription Switches

   • Eric P. Brass

   Letter to the Editor 18 October 2023 Pages: 16 - 17

4. Risk-Based Quality Management: Who Should Be in the Room and When While Assessing Risks During a Clinical Trial?

   • Terry Katz
   • Maryrose Petrizzo
   • Munish Mehra

   Letter to the Editor 07 November 2023 Pages: 18 - 20

5. Regulatory Framework, Challenges, and Initial Strategic Planning for Advanced Therapy Products (PTAs) Development in Brazil

   • Flávia Nathiely Silveira Fachel
   • Roselena Silvestri Schuh
   • Ursula Matte

   Review 10 October 2023 Pages: 21 - 33

   

6. Use of Real-World Evidence in Regulatory Decisions for Traditional Chinese Medicine: Current Status and Future Directions

   • Pei Li
   • Su Wang
   • Yuwen Chen

   Review Open access 23 November 2023 Pages: 34 - 41

7. Enrollment Forecast for Clinical Trials at the Planning Phase with Study-Level Historical Data

   • Mengjia Yu
   • Sheng Zhong
   • Li Wang

   Original Research 15 September 2023 Pages: 42 - 52

   

8. Knowledge and Attitudes of Clinical Trials among Patients with Rare Diseases and the Guardians in China

   • Ziling Xiang
   • Hui Jiang
   • Hang Zheng

   Original Research 18 September 2023 Pages: 53 - 62

   

9. Patient Engagement and Patient Experience Data in Regulatory Review and Health Technology Assessment: A Global Landscape Review

   • Neil Bertelsen
   • Lode Dewulf
   • Nicholas Brooke

   Original Research Open access 24 September 2023 Pages: 63 - 78

   

10. Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations

    • Marina Ghadanian
    • Ellen Schafheutle

    Original Research Open access 20 October 2023 Pages: 79 - 113

    

11. Imputation of Missing Data for Time-to-Event Endpoints Using Retrieved Dropouts

    • Shuai Wang
    • Robert Frederich
    • James P. Mancuso

    Original Research Open access 07 October 2023 Pages: 114 - 126

    

12. Non-monotone Exponential Time (NEXT) Model for the Longitudinal Trend of a Continuous Outcome in Clinical Trials

    • Ran Duan
    • Kaiyi Chen
    • Yongming Qu

    Original Research 26 September 2023 Pages: 127 - 135

    

13. Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan

    • Akira Ito
    • Mamoru Narukawa

    Original Research 03 October 2023 Pages: 136 - 142

    

14. New Benchmarks on Demographic Disparities in Pivotal Trials Supporting FDA-Approved Drugs and Biologics

    • Zachary Smith
    • Emily Botto
    • Kenneth Getz

    Original Research 29 September 2023 Pages: 143 - 152

15. An Evaluation of the Swissmedic Regulatory Framework for New Active Substances

    • Magda Bujar
    • Simon Andreas Dalla Torre di Sanguinetto
    • Neil McAuslane

    Original Research Open access 26 October 2023 Pages: 153 - 165

    

16. Safety of Intravenous Pantoprazole Sodium in Pediatric Patients Aged 1 Month to < 1 Year: A Real-World Retrospective Cohort Study

    • Sampada Gandhi
    • Benjamin Taylor
    • Kevin Wolter

    Original Research 27 October 2023 Pages: 166 - 174

    

17. Quantifying Clinical Trial Diversity in Pivotal Registration Trials of FDA Novel Drug Approvals

    • Muhammed Y. Idris
    • William E. Fitzsimmons
    • Priscilla Pemu

    Original Research 23 October 2023 Pages: 175 - 183

18. Use of Mean Kinetic Temperature for Pharmaceuticals in Japan and Stability Monitoring in the 21st Century

    • Ensei Miura

    Original Research 27 October 2023 Pages: 184 - 191

    

19. Lower Risks of Gastrointestinal Perforation and Intestinal Obstruction in Patients with Atypical Antipsychotics in Comparison with Typical Antipsychotics Based on Real-World Data from the MID-NET^® in Japan

    • Tomoaki Hasegawa
    • Sono Sawada
    • Yoshiaki Uyama

    Original Research Open access 29 October 2023 Pages: 192 - 199

    

20. An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space

    • Sheena Dupuy
    • Laura Opincar
    • Evelyn R. Hermes-DeSantis

    Original Research Open access 10 November 2023 Pages: 200 - 213

    

21. Decisions on Non-oncology Breakthrough Therapy Designation Requests in 2017–2019

    • Atasi Poddar
    • Miranda Raggio
    • John Concato

    Original Research Open access 05 November 2023 Pages: 214 - 221