1. The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications

   • Rhonda M. Hearns-Stewart
   • John Farley
   • Kevin Bugin

   Analytical Report 24 November 2020 Pages: 467 - 472

2. Correction to: The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications

   • Rhonda M. Hearns-Stewart
   • John Farley
   • Kevin Bugin

   Correction 16 December 2020 Pages: 473 - 473

3. Evaluation of the Regulatory Review Process in Zimbabwe: Challenges and Opportunities

   • Tariro Sithole
   • Gugu Mahlangu
   • Stuart Walker

   Original Research Open access 02 January 2021 Pages: 474 - 489

   

4. Biosimilars in Malaysia: Regulatory Framework, Approved Products, and Adverse Effects

   • Noraisyah Mohd Sani
   • Zoriah Aziz
   • Adeeba Kamarulzaman

   Review 24 November 2020 Pages: 490 - 502

   

5. New Drug and Biologics Approvals in 2019: A Systematic Analysis of Patient Experience Data in FDA Drug Approval Packages and Product Labels

   • Katrine Schultz-Knudsen
   • Ugne Sabaliauskaite
   • Anne Vinther Morant

   Original Research Open access 23 November 2020 Pages: 503 - 513

   

6. Allopurinol-Induced Severe Cutaneous Adverse Drug Reactions: An Analysis of Spontaneous Reports in Malaysia (2000–2018)

   • Sing Chet Lee
   • Wee Kee Wo
   • Vidhya Hariraj

   Original Research 03 January 2021 Pages: 514 - 522

   

7. Efficacy Comparison for a Schizophrenia and a Dysuria Drug Among East Asian Populations: A Retrospective Analysis Using Multi-regional Clinical Trial Data

   • Kimie Sai
   • Eiji Nakatani
   • Yoshiro Saito

   Original Research 03 January 2021 Pages: 523 - 538

   

8. Effect of Hepatitis C Drugs on Blood Coagulability in Patients on Warfarin Using the Medical Information Database Network (MID-NET^®) in Japan

   • Sono Sawada
   • Takashi Ando
   • Yoshiaki Uyama

   Original Research Open access 03 January 2021 Pages: 539 - 544

   

9. Real-World Data for Planning Eligibility Criteria and Enhancing Recruitment: Recommendations from the Clinical Trials Transformation Initiative

   • Scott R. Evans
   • Dianne Paraoan
   • Zachary P. Hallinan

   Analytical Report Open access 03 January 2021 Pages: 545 - 552

   

10. Has the COVID-19 Crisis Affected the Growth of United States Food and Drug Administration Drug Approvals? The Answer is Not Yet! A Time Series (Forecasting) Study

    • Iraj Daizadeh

    Commentary 26 December 2020 Pages: 553 - 557

    

11. Open Science to Address COVID-19: Sharing Data to Make Our Research Investment Go Further

    • Névine Zariffa
    • Jonas Haggstrom
    • Frank Rockhold

    Letter to the Editor Open access 24 December 2020 Pages: 558 - 560

12. Demonstrating that Real World Evidence Is Fit-For-Purpose to Support Labeling: Parallels to Patient Reported Outcomes in the Pursuit of Labeling Claims

    • Cynthia J. Girman
    • Mary E. Ritchey
    • Robert J. Meyer

    Commentary 28 January 2021 Pages: 561 - 567

    

13. Review of the Food and Drug Administration’s Center for Drug Evaluation and Research Program for New Molecular Entities: Trends and Regulatory Requirements in Acknowledgment Letters and Filing Communications

    • Jennifer Riddle Camp
    • Jillian Venci Fuhs
    • Richard D. Hoffman

    Review 25 January 2021 Pages: 568 - 582

    

14. Implementation of Quality by Design (QbD) Principles in Regulatory Dossiers of Medicinal Products in the European Union (EU) Between 2014 and 2019

    • Judith P. ter Horst
    • Sada L. Turimella
    • Alex Zwiers

    Original Research Open access 13 January 2021 Pages: 583 - 590

    

15. Effective Data Sharing as a Conduit for Advancing Medical Product Development

    • Stephen R. Karpen
    • J. Kael White
    • Jane Larkindale

    Review Open access 04 January 2021 Pages: 591 - 600

    

16. Evaluation of Clinical Trials in Onco-haematology: A New Method Based on Risk Analysis and Multidisciplinarity

    • J. Lapière
    • C. Christen
    • N. Albin

    Original Research 27 January 2021 Pages: 601 - 611

    

17. How to Interpret an Investigator’s Brochure for Meaningful Risk Assessment: Results of an AGAH Discussion Forum

    • Jens Rengelshausen
    • Kerstin Breithaupt-Groegler
    • Hildegard Sourgens

    Original Research Open access 03 February 2021 Pages: 612 - 618

18. Expedited Development Programs at the Food and Drug Administration: Insights and Opportunities

    • Grace Collins
    • Mark Stewart
    • Jeff Allen

    Letter to the Editor Open access 02 February 2021 Pages: 619 - 621

    

19. Hypothalamic–Pituitary–Adrenal Axis Pediatric Safety Studies Submitted to the FDA

    • Janelle M. Burnham
    • Dionna J. Green
    • Gilbert J. Burckart

    Original Research 05 February 2021 Pages: 622 - 630

    

20. Letter to the Editor: New Approaches to Regulatory Innovation Emerging During the Crucible of COVID-19

    • Timothé Ménard

    Letter to the Editor 22 March 2021 Pages: 631 - 632