1. Glory Enough for All

   • Stephen P. Spielberg

   Editorial 30 December 2016 Pages: 681 - 681

2. Optimizing the Use of Electronic Data Sources in Clinical Trials: The Landscape, Part 1

   • Ed Kellar
   • Susan M. Bornstein
   • Brett Wilson

   Sponsored Special Section by TransCelerate BioPharma: Original Research Open access 30 December 2016 Pages: 682 - 696

3. An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research: 2003 Through 2014

   • Khushboo Sharma
   • Afi Harrington
   • Amy Bertha

   Regulatory Science: Analytical Report 30 December 2016 Pages: 697 - 704

4. Expanded Access of Investigational Drugs: The Experience of the Center of Drug Evaluation and Research Over a 10-Year Period

   • Jonathan P. Jarow
   • Steven Lemery
   • Richard Moscicki

   Regulatory Science: Original Research 30 December 2016 Pages: 705 - 709

5. Adaptive Design Practice at the Center for Devices and Radiological Health (CDRH), January 2007 to May 2013

   • Xiting Yang
   • Laura Thompson
   • Gerry W. Gray

   Regulatory Science: Analytical Report 30 December 2016 Pages: 710 - 717

6. Implementation of Structured Benefit-Risk Assessments in Marketing Authorization Applications: Lessons Learned

   • JuAn Wang
   • Anne Wolka
   • Rebecca Noel

   Regulatory Science: Original Research 30 December 2016 Pages: 718 - 723

7. Prospects for Harmonizing Regulatory Science Programs in Europe, Japan, and the United States to Advance Regenerative Medicine

   • Christopher-Paul Milne
   • James Mittra
   • Gabrielle Simmons

   Global Perspectives: Original Research 30 December 2016 Pages: 724 - 733

8. An Analysis of Regulatory Timing and Outcomes for New Drug Applications Submitted to Swissmedic: Comparison With the US Food and Drug Administration and the European Medicines Agency

   • Petra Dörr
   • Alison Wadworth
   • Lawrence Liberti

   Global Perspectives: Original Research 30 December 2016 Pages: 734 - 742

9. Comparison of Drug Use Between Clinical Practice and Regulatory Approval: Results in Older Japanese Patients With Rheumatoid Arthritis, Diabetes, High Blood Pressure, or Depression

   • Nanae Tanemura
   • Yoshiaki Uyama
   • Hideki Hanaoka

   Global Perspectives: Original Research 30 December 2016 Pages: 743 - 750

10. Evaluating the Effectiveness of Repricing for Market Expansion in the Japanese Drug Pricing System

    • Shoyo Shibata
    • Ryotaro Uemura
    • Takeshi Suzuki

    Global Perspectives: Original Research 30 December 2016 Pages: 751 - 758

11. Public- and Private-Sector Contributions to the Research and Development of the Most Transformational Drugs in the Past 25 Years: From Theory to Therapy

    • Ranjana Chakravarthy
    • Kristina Cotter
    • Nils Wendel

    Product Development and Innovation: Original Research 30 December 2016 Pages: 759 - 768

12. Drug Target Identification and Validation: Global Pharmaceutical Industry Experts on Challenges, Best Strategies, Innovative Precompetitive Collaboration Concepts, and Future Areas of Industry Precompetitive Research and Development

    • Tobias Bergauer
    • Thorsten Ruppert
    • Olivia Spleiss

    Product Development and Innovation: Analytical Report 30 December 2016 Pages: 769 - 776

13. Novel Gastroretentive Controlled Release Formulations for Once-Daily Administration: Assessment of Clinical Feasibility and Formulation Concept for Raltegravir

    • Rajesh Krishna
    • Matthew L. Rizk
    • Philip Evans

    Product Development and Innovation: Original Research 30 December 2016 Pages: 777 - 790

14. A Toolkit for the Management of Protocol Deviations

    • Sandy Mohan
    • Munish Mehra
    • Terry Katz

    Clinical Trials: Original Research 30 December 2016 Pages: 791 - 800

15. Pharmaceutical Organizational Size and Phase 3 Clinical Trial Completion Times

    • Harold E. Glass
    • Lucas M. Glass
    • Hani Alghamdi

    Clinical Trials: Original Research 30 December 2016 Pages: 801 - 807

16. Can Registration Procedures of Pharmaceuticals Inadvertently Contribute to Off-Label Prescribing in Children?

    • Ian Ellul
    • Victor Grech
    • Simon Attard-Montalto

    Special Populations: Original Research 30 December 2016 Pages: 808 - 816

17. Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development

    • Ann W. McMahon
    • Kevin Watt
    • Gilbert J. Burckart

    Special Populations: Original Research 30 December 2016 Pages: 817 - 822

18. Postmarketing Benefit-Risk Assessment for Erythropoiesis-Stimulating Agents Using a Health Care Database

    • Yasuo Sugitani
    • Yukio Udagawa
    • Ichiro Konishi

    Product Safety: Original Research 30 December 2016 Pages: 823 - 832

19. A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

    • Patrick M. Schnell
    • Greg Ball

    Product Safety: Original Research 30 December 2016 Pages: 833 - 838

20. The PharmD/MD Dual-Degree Program and Its Potential Value in the Pharmaceutical Industry

    • Khushbu S. Shah
    • Upasana Marwah
    • John L. Colaizzi

    Policy: Review 30 December 2016 Pages: 839 - 845

21. Current Practice on Multiplicity Adjustment and Sample Size Calculation in Multi-arm Clinical Trials: An Industry Survey in Japan

    • Kentaro Sakamaki
    • Toshifumi Kamiura
    • Hideki Suganami

    Statistics: Original Research 30 December 2016 Pages: 846 - 852