1. Transitions, Introductions, and a Notable Announcement From the US FDA in December 2016

   • J. Rick Turner

   Editorial 30 December 2017 Pages: 140 - 141

2. Introduction to the “Right to Try” Special Section

   • David Vulcano

   Special Section on “Right to Try”: Editorial 30 December 2017 Pages: 142 - 142

3. A Global Perspective on Compassionate Use and Expanded Access

   • Tom Watson

   Special Section on “Right to Try”: Commentary 30 December 2017 Pages: 143 - 145

4. Considerations for Use of Investigational Drugs in Public Health Emergencies

   • Matthew Carl Kirchoff
   • Jerome F. Pierson

   Special Section on “Right to Try” 30 December 2017 Pages: 146 - 152

5. Reconciling States’ “Right to Try” Legislation and FDA’s Expanded Access Program: Legal Issues

   • Robyn S. Shapiro

   Special Section on “Right to Try”: Commentary 30 December 2017 Pages: 153 - 156

6. Accelerated Access to Medicines: An Ethical Analysis

   • Jessica Pace
   • Narcyz Ghinea
   • Wendy Lipworth

   Special Section on “Right to Try”: Analytical Report 30 December 2017 Pages: 157 - 163

7. Preapproval Access and Right-to-Try Initiatives: What Are We Willing to Give Up?

   • Art Gertel

   Special Section on “Right to Try”: Commentary 30 December 2017 Pages: 164 - 169

8. Who Stands to Benefit? Right to Try Law Provisions and Implications

   • Lisa Kearns
   • Alison Bateman-House

   Special Section on “Right to Try”: Original Article 30 December 2017 Pages: 170 - 176

9. Overview of FDA’s Expanded Access Program for Investigational Drugs

   • Jonathan P. Jarow
   • Peter Lurie
   • Steven Lemery

   Special Section on “Right to Try”: Analytical Report 30 December 2017 Pages: 177 - 179

10. Book Review: Cardiovascular Safety in Drug Development and Therapeutic Use

    • Jonathan H. Seltzer

    Book Review 30 December 2017 Pages: 180 - 180

11. Sample Size Calculations for Combination Drugs of 2 Monotherapies With a Single Approved Dose Level: Binary Endpoint Cases

    • Seung-Ho Kang
    • Juhee Park

    Biostatistics: Original Research 30 December 2017 Pages: 181 - 189

12. Ethical Considerations in Adaptive Design Clinical Trials

    • Thomas Laage
    • John W. Loewy
    • Christopher Coffey

    Clinical Trials: Review 30 December 2017 Pages: 190 - 199

13. Challenges With the Development of Biosimilars in Asia for Western Markets: An Overview and Suggested Solutions

    • Raymond A. Huml
    • Oxana Iliach
    • Nigel R. Rulewski

    Global Perspectives: Original Research 30 December 2017 Pages: 200 - 206

14. An Analysis of Japanese Patients Enrolled in Multiregional Clinical Trials in Oncology

    • Akihiro Hirakawa
    • Fumie Kinoshita

    Global Perspectives: Analytical Report 30 December 2017 Pages: 207 - 211

15. A Cross-Sectional Study on the Use of, Preference for, and Perceived Reliability of Mass Media for Drug-Related Information Among the General Public in Sarawak

    • Chuo Yew Ting
    • Mohd Shahezwan Abd Wahab
    • Long Chiau Ming

    Global Perspectives: Original Research 30 December 2017 Pages: 212 - 220

16. Goods and Services Tax on Pharmaceuticals in Malaysia

    • Zhi Yen Wong
    • Alian A. Alrasheedy
    • Fahad Saleem

    Global Perspectives: Commentary 30 December 2017 Pages: 221 - 223

17. Accelerated Pathways Work—Now What? A Survey of Payers in the United States

    • Barry Farrimond
    • Jonathan J. Fleming
    • Mark Mathieu

    Product Development and Innovation: Original Research 30 December 2017 Pages: 224 - 231

18. Characteristics That May Help in the Identification of Potentially Confusing Proprietary Drug Names

    • Millie B. Shah
    • Lubna Merchant
    • Kellie Taylor

    Product Safety: Original Research 30 December 2017 Pages: 232 - 236

19. Innovation for Safe and Effective Medical Devices: Contributions From Postmarket Surveillance

    • Claus Zippel
    • Sabine Bohnet-Joschko

    Product Safety: Original Research 30 December 2017 Pages: 237 - 245

20. Ten-Year Experience for the Center for Drug Evaluation and Research, Part 2: FDA’s Role in Ensuring Patient Safety

    • Jonathan P. Jarow
    • Steven Lemery
    • Naomi Lowy

    Product Safety: Original Research 30 December 2017 Pages: 246 - 249

21. Assessing the Quality of Decision Making in the Development and Regulatory Review of Medicines: Identifying Biases and Best Practices

    • Magdalena Bujar
    • Ronan Donelan
    • Sam Salek

    Regulatory Science 30 December 2017 Pages: 250 - 256

22. Patient Voice in Rare Disease Drug Development and Endpoints

    • Linda S. Deal
    • Jonathan C. Goldsmith
    • David H. Schubert

    Special Populations: Commentary 30 December 2017 Pages: 257 - 263