A Vision for Therapeutic Innovation & Regulatory Science Gregory Daniel Editorial 23 December 2019 Pages: 169 - 169
Comparison of Sample Size by Bootstrap and by Formulas Based on Normal Distribution Assumption Zuozhen Wang Biostatistics: Statistics 23 December 2019 Pages: 170 - 175
Risk-Based Data Monitoring: Quality Control in Central Nervous System (CNS) Clinical Trials Cynthia McNamaraNina EngelhardtGuillermo Di Clemente Clinical Trials: Analytical Reports 23 December 2019 Pages: 176 - 182
Risk-Based Monitoring (RBM) Implementation: Challenges and Potential Solutions Nimita LimayeVeena Jaguste Clinical Trials 23 December 2019 Pages: 183 - 189
An Institutional Program to Increase Compliance with Clinicaltrials.gov Requirements Issis Kelly-PumarolJoseph E. Andrews Jr. Clinical Trials: Commentary 23 December 2019 Pages: 190 - 192
Regulatory/Scientific Supports for Micro-, Small-, and Medium-Sized Enterprises (SMEs) With Medicinal Products Provided by the PMDA and EMA Hideyuki KondoMasayoshi ShibatsujiNaoyuki Yasuda Global Perspectives: Commentary 23 December 2019 Pages: 193 - 198
Influence of Expedited Programs in the United States on Oncology Drug Development in Japan Makoto TanakaNaoki MatsumaruKatsura Tsukamoto Global Perspectives: Original Article 23 December 2019 Pages: 199 - 206
Opportunities and Challenges of Multinational Pharmaceutical Enterprises in Transforming Pharmaceutical Market in China Linfeng HuZhong YuCarolina Oi Lam Ung Global Perspectives: Review 23 December 2019 Pages: 207 - 214
Comparison of International Regulations for Written Medicine Information (WMI) on Prescription Medicines Hsiu-Chun Tony YuanDavid K. RaynorParisa Aslani Global Perspectives: Review 23 December 2019 Pages: 215 - 226
Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China Jun WangGang WangJinbo Yang Global Perspectives: Review 23 December 2019 Pages: 227 - 232
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 ChoKi Hwan ChoiYhun Yhong Sheen Global Perspectives: Review 23 December 2019 Pages: 233 - 242
A Pilot Experiment in Responding to Individual Patient Requests for Compassionate Use of an Unapproved Drug: The Compassionate Use Advisory Committee (CompAC) Arthur CaplanAlison Bateman-HouseRick Jansson Patient Engagement: Original Article 23 December 2019 Pages: 243 - 248
The Author(s) Pharmacovigilance and Risk Management Strategies 2017: Overview of the Generic Drug Program and Surveillance Howard D. ChazinJohn R. PetersKaren B. Feibus Regulatory Science: Review 23 December 2019 Pages: 249 - 253
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. LanceRuth V. GreenawayBrian Edwards Regulatory Science: Review 23 December 2019 Pages: 254 - 263
Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations Iraj Daizadeh Regulatory Science: Original Article 23 December 2019 Pages: 264 - 269
Accelerating Pediatric Cancer Drug Development: Challenges and Opportunities for Pediatric Master Protocols Tahira KhanMark StewartGregory Reaman Special Populations: Meeting Report 23 December 2019 Pages: 270 - 278
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 TheilgaardInger Mollerupon behalf of the DEVOTE Study Group Special Populations: Original Article 23 December 2019 Pages: 279 - 286
