1. First Approval of Generic Mometasone Furoate Nasal Suspension Spray in Japan: Similarities and Differences Between Japan and the USA

   • Ryosuke Kuribayashi
   • Miho Kasuga
   • Toru Yamaguchi

   Commentary 13 September 2022 Pages: 173 - 177

   

2. Implementation of a Pharmacovigilance System in a Resources-Limited Country in the Context of COVID-19: Lebanon’s Success Story

   • Hanine Abbas
   • Abeer Zeitoun
   • Rita Karam

   Review 15 September 2022 Pages: 178 - 185

   

3. Considerations for Embedding Inclusive Research Principles in the Design and Execution of Clinical Trials

   • Ubong Peters
   • Brenna Turner
   • Shilpen Patel

   Review Open access 14 October 2022 Pages: 186 - 195

   

4. A Proposal for Post Hoc Subgroup Analysis in Support of Regulatory Submission

   • Jiajun Liu
   • Shein-Chung Chow

   Original Research 13 September 2022 Pages: 196 - 208

   

5. Assessing the Financial Value of Decentralized Clinical Trials

   • Joseph A. DiMasi
   • Zachary Smith
   • Kenneth A. Getz

   Original Research Open access 14 September 2022 Pages: 209 - 219

   

6. Influence Diagnostics of a Region of Interest in Multi-regional Clinical Trials

   • Kazuhiko Kuribayashi
   • Charlie Cao

   Original Research 15 September 2022 Pages: 220 - 226

   

7. Regulatory Environment and Approvals in Cell and Gene Therapy Products Between Japan, the USA, and the EU

   • Yuya Sato
   • Shunsuke Ono

   Original Research 16 September 2022 Pages: 227 - 237

   

8. Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies and Other Stakeholders

   • Rebecca Baines
   • Petra Hoogendoorn
   • Simon Leigh

   Original Research Open access 04 October 2022 Pages: 238 - 250

   

9. Survey Result for E-labeling Initiatives in Asia

   • Rie Matsui
   • Koji Yamaguchi
   • Runyi Mo

   Original Research Open access 10 October 2022 Pages: 251 - 260

   

10. Publisher Correction: Survey Result for E-labeling Initiatives in Asia

    • Rie Matsui
    • Koji Yamaguchi
    • Runyi Mo

    Publisher Correction Open access 31 October 2022 Pages: 261 - 261

11. Insights from a Multi-company Workshop to Apply a Patient Participation Burden Algorithm to Protocol Data

    • Zachary Smith
    • Emily Botto
    • Kenneth Getz

    Original Research 16 October 2022 Pages: 262 - 270

    

12. Regulatory Reform Outcomes and Accelerated Regulatory Pathways for New Prescription Medicines in Australia

    • Alina Yoffe
    • Johnson Liu
    • Orin Chisholm

    Original Research Open access 21 October 2022 Pages: 271 - 286

    

13. A Retrospective Analysis of Applications for Registration of Generic Medicines Processed by the Medicines Control Authority of Zimbabwe

    • Brilliant Tinashe Samunda
    • Tariro Sithole
    • Star Khoza

    Original Research Open access 21 October 2022 Pages: 287 - 294

14. Does Central Monitoring Lead to Higher Quality? An Analysis of Key Risk Indicator Outcomes

    • Sylviane de Viron
    • Laura Trotta
    • Marc Buyse

    Original Research Open access 21 October 2022 Pages: 295 - 303

    

15. Sample Sizes Using Hochberg’s Procedure for Two Comparisons with Three Different Study Designs

    • David R. Bristol

    Original Research 24 October 2022 Pages: 304 - 315

    

16. A Generalization of the Two Trials Paradigm

    • Gerd K. Rosenkranz

    Original Research 26 October 2022 Pages: 316 - 320

17. Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations

    • Zahra Hanaizi
    • Sandra Kweder
    • Anabela Marcal

    Original Research Open access 28 October 2022 Pages: 321 - 328

    

18. Risks of Myocarditis and Pericarditis Following Vaccination with SARS-CoV-2 mRNA Vaccines in Japan: An Analysis of Spontaneous Reports of Suspected Adverse Events

    • Hidetaka Kobayashi
    • Sayoko Fukuda
    • Toyotaka Iguchi

    Original Research 30 October 2022 Pages: 329 - 342

    

19. Trends and Characteristics of New Drug Approvals in China, 2011–2021

    • Ling Su
    • Sen Liu
    • Xiaoyuan Chen

    Original Research Open access 02 November 2022 Pages: 343 - 351

    

20. Safety and Effectiveness of Multiple Switching Between Originators and Biosimilars: Literature Review and Status Report on Interchangeability

    • Ruggero Lasala
    • Paolo Abrate
    • Fiorenzo Santoleri

    Original Research 02 November 2022 Pages: 352 - 364

    

21. Analyzing Longitudinal Data from Glaucoma Trials

    • Phillip Dinh

    Original Research 09 November 2022 Pages: 365 - 371

    

22. Evaluation of the Food and Drugs Authority, Ghana Regulatory Review Process: Challenges and Opportunities

    • Mercy Owusu-Asante
    • Delese Mimi Darko
    • Sam Salek

    Original Research Open access 09 November 2022 Pages: 372 - 385

    

23. Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies

    • Scott W. Roberts
    • Tara Laura Brandt Elvang
    • Tue Anker Mikkelsen

    Original Research 18 November 2022 Pages: 386 - 395

24. Correction: Regulatory Considerations Toward Orphan Drug Designation and Orphan Drug Exclusivity in the United States and European Union: Structural Similarity, Clinical Superiority/Significant Benefit, and Case Studies

    • Scott W. Roberts
    • Tara Laura Brandt Elvang
    • Tue Anker Mikkelsen

    Correction 06 December 2022 Pages: 396 - 398