1. MedDRA Labeling Groupings to Improve Safety Communication in Product Labels

   • Ilona Große-Michaelis
   • Scott Proestel
   • William Gregory

   Commentary Open access 08 August 2022 Pages: 1 - 6

2. Path Forward to Optimise Post-approval Change Management and Facilitate Continuous Supply of Medicines and Vaccines of High Quality Worldwide

   • Andrew Deavin
   • Sarah Adam
   • Charlie Mortazavi

   Commentary Open access 02 August 2022 Pages: 7 - 11

   

3. Asia Partnership Conference of Pharmaceutical Associations (APAC) Report on Regulatory Agility Implemented During the COVID-19 Pandemic: Inspiring Partnerships and Recommendations for the Way Forward

   • Sannie Siaw Foong Chong
   • Masaaki Kanno
   • Richard Simon R. Binos

   Original Research Open access 29 September 2022 Pages: 12 - 25

   

4. Magistral Compounding with 3D Printing: A Promising Way to Achieve Personalized Medicine

   • Netta Beer
   • Susanne Kaae
   • Ingrid Hegger

   Original Research Open access 09 August 2022 Pages: 26 - 36

   

5. Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019

   • Mei Kohama
   • Takahiro Nonaka
   • Chieko Ishiguro

   Original Research 13 August 2022 Pages: 37 - 47

   

6. Correction: Descriptive Analysis for the Trend of Pharmacovigilance Planning in Risk Management Plans on New Drugs Approved During 2016–2019

   • Mei Kohama
   • Takahiro Nonaka
   • Chieko Ishiguro

   Correction 25 August 2022 Pages: 48 - 48

7. Protocol Design and Performance Benchmarks by Phase and by Oncology and Rare Disease Subgroups

   • Kenneth Getz
   • Zachary Smith
   • Marcy Kravet

   Original Research 12 August 2022 Pages: 49 - 56

8. Pharmacometrics: The Already-Present Future of Precision Pharmacology

   • Lorena Cera Bandeira
   • Leonardo Pinto
   • Cláudia Martins Carneiro

   Review 18 August 2022 Pages: 57 - 69

   

9. Emergence of New Drugs for Intractable Diseases is Associated with an Increase in the Number of Patients Diagnosed Thereafter with Those Intractable Diseases

   • Toshiya Oka
   • Mamoru Narukawa

   Original Research 08 August 2022 Pages: 70 - 78

   

10. Comparison of Good Clinical Practice Inspection Processes for Marketing Applications Between the United States Food and Drug Administration and the European Medicines Agency

    • Kassa Ayalew
    • Yang-Min Ning
    • Ni A. Khin

    Original Research Open access 16 August 2022 Pages: 79 - 85

    

11. Comprehensive Analysis of Clinical Studies and Regulations of Therapeutic Applications in the United States and Japan

    • Mao Ono
    • Kiyotaka Iwasaki

    Original Research Open access 07 September 2022 Pages: 86 - 99

    

12. Twenty-First Century Global ADR Management: A Need for Clarification, Redesign, and Coordinated Action

    • Hervé Le Louët
    • Peter J. Pitts

    Commentary 11 August 2022 Pages: 100 - 103

13. Japanese Regulatory Considerations for Interoperability of Medical Devices

    • Kazuma Ishimoto
    • Tatsuhiko Arafune
    • Masuo Kondoh

    Analytical Report 22 August 2022 Pages: 104 - 108

    

14. Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation

    • Thomas R. Fleming
    • Christine E. Garnett
    • Lynne Yao

    Original Research Open access 03 September 2022 Pages: 109 - 120

    

15. Relative Risk Assessment for Substandard Antibiotics Along the Manufacturing and Supply Chain: A Proof-of-Concept Study

    • Carly Ching
    • Mohammad Ahsan Fuzail
    • Veronika J. Wirtz

    Original Research 25 August 2022 Pages: 121 - 131

    

16. The Midazolam RAMPART Study Medical Records Project: A Unique Use of Real-World Data in a Complex Collaborative Partnership to Support a New Drug Application

    • Nancy A. Sherman
    • Robert Silbergleit
    • Kevin D. Wolter

    Original Research Open access 20 August 2022 Pages: 132 - 141

    

17. Bayesian Method of Borrowing Study-Level Historical Longitudinal Control Data for Mixed-Effects Models with Repeated Measures

    • Hong Li
    • Man Jin
    • Li Wang

    Original Research 31 October 2022 Pages: 142 - 151

    

18. Leveraging Patient Preference Information in Medical Device Clinical Trial Design

    • Liliana Rincon-Gonzalez
    • Wendy K. D. Selig
    • Barry Liden

    Analytical Report Open access 27 August 2022 Pages: 152 - 159

19. The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals

    • Duane Schulthess
    • Harry P. Bowen
    • Joe Hammang

    Original Research Open access 03 September 2022 Pages: 160 - 169

    

20. Correction: The Relative Contributions of NIH and Private Sector Funding to the Approval of New Biopharmaceuticals

    • Duane Schulthess
    • Harry P. Bowen
    • Joe Hammang

    Correction Open access 16 September 2022 Pages: 170 - 171