1. An FDA Analysis of Inspected Entities After Receiving Official Action Indicated Letters for Good Clinical Practice Violations

   • Miah Jung
   • Rachelle M. Swann
   • Faranak Jamali

   Original Research Open access 08 June 2021 Pages: 907 - 917

   

2. Biennial Analysis of Medication Guide Length and Estimated Readability for New Molecular Entity Drugs, 2011–2017

   • Paul R. Jones
   • Elisabeth J. Walther
   • Bryon M. Pearsall

   Original Research 10 May 2021 Pages: 918 - 925

3. Streamlined Operational Approaches and Use of e-Technologies in Clinical Trials: Beat Acute Myeloid Leukemia Master Trial

   • Len Rosenberg
   • Hugh Levaux
   • Amy Burd

   Original Research Open access 16 May 2021 Pages: 926 - 935

   

4. Sustaining Meaningful Patient Engagement Across the Lifecycle of Medicines: A Roadmap for Action

   • Maria Cavaller-Bellaubi
   • Stuart D. Faulkner
   • Elisa Ferrer

   Original Research Open access 10 May 2021 Pages: 936 - 953

   

5. Evaluating Metrics Applied to the Medical Science Liaison (MSL) Role: A Survey-Based Study of Canadian MSL Leaders

   • Munaza Saleem
   • Lisa Cesario
   • Andrew Chilelli

   Original Research Open access 04 May 2021 Pages: 954 - 965

   

6. Investigator Initiated Clinical Trials (IICTs): A Systematic Search in Registries to Compare the Czech Republic and Portugal in Terms of Funding Policies and Scientific Outcomes

   • C. Madeira
   • L. Hořavová
   • E. C. Monteiro

   Original Research Open access 18 May 2021 Pages: 966 - 978

   

7. Cutting Through the “Gray Area”: An Analysis of the IBC Regulatory Oversight of Applications of CRISPR Technology in Clinical Research

   • Westley F. Weiss

   Analytical Report 18 May 2021 Pages: 979 - 983

8. Implementation of ICH E9 (R1): A Few Points Learned During the COVID-19 Pandemic

   • Yongming Qu
   • Ilya Lipkovich

   Analytical Report 13 May 2021 Pages: 984 - 988

   

9. Addressing Bias in Responder Analysis of Patient-Reported Outcomes

   • Joseph C. Cappelleri
   • Richard Chambers

   Original Research Open access 27 May 2021 Pages: 989 - 1000

   

10. Proof of Concept: Drug Selection? Or Dose Selection? Thoughts on Multiplicity Issues

    • Qian H. Li
    • Qiqi Deng
    • Naitee Ting

    Original Research 24 May 2021 Pages: 1001 - 1005

11. Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates

    • Beth Harper
    • Zachary Smith
    • Ken Getz

    Original Research 07 May 2021 Pages: 1006 - 1012

    

12. Correction to: Characterizing Pain Points in Clinical Data Management and Assessing the Impact of Mid-Study Updates

    • Beth Harper
    • Zachary Smith
    • Ken Getz

    Correction 17 May 2021 Pages: 1013 - 1013

13. The Role of Regulatory Sciences from the Perspective of the Cuban Medicines Regulatory Agency: The Impact of COVID-19 in Promoting Innovation, Cooperation and Scientific Thinking

    • Belkis Romeu
    • Yaquelín Rodríguez
    • Silvia Bendiner

    Commentary 03 May 2021 Pages: 1014 - 1018

    

14. The Use of External Controls in FDA Regulatory Decision Making

    • Mahta Jahanshahi
    • Keith Gregg
    • Sharon Sakai

    Review Open access 20 May 2021 Pages: 1019 - 1035

    

15. Oncology Products in the European Union: An Analysis of Regulatory Approvals with a CHMP Oral Explanation

    • Alexandra Oger
    • Aimad Torqui
    • Sacha Wissink

    Original Research 26 May 2021 Pages: 1036 - 1044

    

16. Innovation Pathways in the NHS: An Introductory Review

    • Anmol Arora
    • Andrew Wright
    • Matthew Seah

    Review Open access 19 May 2021 Pages: 1045 - 1058

    

17. Patient Engagement Initiatives in Clinical Trials: Recent Trends and Implications

    • Shalome Sine
    • Annick de Bruin
    • Kenneth Getz

    Original Research Open access 07 June 2021 Pages: 1059 - 1065

    

18. Clinical Quality Considerations when Using Next-Generation Sequencing (NGS) in Clinical Drug Development

    • Timothé Ménard
    • Alaina Barros
    • Christopher Ganter

    Review Open access 27 May 2021 Pages: 1066 - 1074

    

19. Factors Influencing Classifications of Safety Specifications in a Risk Management Plan for Antineoplastic Agents Approved in Japan: A Review and Descriptive Analysis

    • Asami Ezaki
    • Akihiro Hirakawa
    • Yoshiaki Uyama

    Original Research 09 June 2021 Pages: 1075 - 1081

    

20. Measuring What Matters for Children: A Systematic Review of Frequently Used Pediatric Generic PRO Instruments

    • Tasneem Arsiwala
    • Nuzhat Afroz
    • Francesco Patalano

    Original Research Open access 17 June 2021 Pages: 1082 - 1095

    

21. Dissolution Profiles of Generic Products in Dissolution Media Defined by Japanese Guidelines for Bioequivalence Studies

    • Eiji Kajiwara
    • Haruki Kamizato
    • Mayumi Shikano

    Original Research 07 June 2021 Pages: 1096 - 1100

    

22. Prescribing Information for Antihypertensive Medications Lacks Dose-Specific Blood Pressure Response

    • Ruchi Vyas
    • Catherine E. Cooke

    Letter to the Editor 14 June 2021 Pages: 1101 - 1102

23. Government Pharmaceutical Development to Address High Prices: Challenges Ahead

    • Jonathan J. Darrow

    Commentary 14 July 2021 Pages: 1103 - 1105