1. A Vision for Therapeutic Innovation & Regulatory Science

   • Gregory Daniel

   Editorial 23 December 2019 Pages: 169 - 169

2. Comparison of Sample Size by Bootstrap and by Formulas Based on Normal Distribution Assumption

   • Zuozhen Wang

   Biostatistics: Statistics 23 December 2019 Pages: 170 - 175

3. Risk-Based Data Monitoring: Quality Control in Central Nervous System (CNS) Clinical Trials

   • Cynthia McNamara
   • Nina Engelhardt
   • Guillermo Di Clemente

   Clinical Trials: Analytical Reports 23 December 2019 Pages: 176 - 182

4. Risk-Based Monitoring (RBM) Implementation: Challenges and Potential Solutions

   • Nimita Limaye
   • Veena Jaguste

   Clinical Trials 23 December 2019 Pages: 183 - 189

5. An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements

   • Issis Kelly-Pumarol
   • Joseph E. Andrews Jr.

   Clinical Trials: Commentary 23 December 2019 Pages: 190 - 192

6. Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA

   • Hideyuki Kondo
   • Masayoshi Shibatsuji
   • Naoyuki Yasuda

   Global Perspectives: Commentary 23 December 2019 Pages: 193 - 198

7. Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

   • Makoto Tanaka
   • Naoki Matsumaru
   • Katsura Tsukamoto

   Global Perspectives: Original Article 23 December 2019 Pages: 199 - 206

8. Opportunities and Challenges of Multinational Pharmaceutical Enterprises in Transforming Pharmaceutical Market in China

   • Linfeng Hu
   • Zhong Yu
   • Carolina Oi Lam Ung

   Global Perspectives: Review 23 December 2019 Pages: 207 - 214

9. Comparison of International Regulations for Written Medicine Information (WMI) on Prescription Medicines

   • Hsiu-Chun Tony Yuan
   • David K. Raynor
   • Parisa Aslani

   Global Perspectives: Review 23 December 2019 Pages: 215 - 226

10. Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

    • Jun Wang
    • Gang Wang
    • Jinbo Yang

    Global Perspectives: Review 23 December 2019 Pages: 227 - 232

11. How Does “Regulatory Practice” Create Discrepancies in Drug Label Information Between Asian and Western Countries? Different Label Information for Direct Oral Anticoagulants Approved in the United States, Europe, Korea, and Japan

    • Il Young Cho
    • Ki Hwan Choi
    • Yhun Yhong Sheen

    Global Perspectives: Review 23 December 2019 Pages: 233 - 242

12. A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC)

    • Arthur Caplan
    • Alison Bateman-House
    • Rick Jansson

    Patient Engagement: Original Article 23 December 2019 Pages: 243 - 248

13. The Author(s) Pharmacovigilance and Risk Management Strategies 2017: Overview of the Generic Drug Program and Surveillance

    • Howard D. Chazin
    • John R. Peters
    • Karen B. Feibus

    Regulatory Science: Review 23 December 2019 Pages: 249 - 253

14. An Assessment of Concerns Regarding New Regulatory Guidance for Combination Products: A Review of the Submissions Made to the FDA Regarding Their Proposed Draft New Guidance on Human Factors Studies for a Combination Product in an Abbreviated New Drug Application

    • Philip T. Lance
    • Ruth V. Greenaway
    • Brian Edwards

    Regulatory Science: Review 23 December 2019 Pages: 254 - 263

15. Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations

    • Iraj Daizadeh

    Regulatory Science: Original Article 23 December 2019 Pages: 264 - 269

16. Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols

    • Tahira Khan
    • Mark Stewart
    • Gregory Reaman

    Special Populations: Meeting Report 23 December 2019 Pages: 270 - 278

17. Developing, Planning and Conducting an Interim Analysis: Lessons From the DEVOTE Cardiovascular Outcomes Trial (Trial Comparing Cardiovascular Safety of Insulin Degludec Versus Insulin Glargine in Patients With Type 2 Diabetes at High Risk of Cardiovascular Events)

    • Hanne Theilgaard
    • Inger Mollerup
    • on behalf of the DEVOTE Study Group

    Special Populations: Original Article 23 December 2019 Pages: 279 - 286