1. Pharmaceutical Compounding: Our First Foray Into Common Ground and Controversies

   • Lisa Jenkins

   Editorial 30 December 2016 Pages: 264 - 265

2. Improving the Quality of Compounded Sterile Drug Products: A Historical Perspective

   • Susan A. Cantrell

   Special Section on Pharmaceutical Compounding 30 December 2016 Pages: 266 - 269

3. Navigating Through a Complex and Inconsistent Regulatory Framework: Section 503B of the Federal Food Drug and Cosmetic Act Outsourcing Facilities Engaged in Clinical Investigation

   • Francis B. Palumbo
   • Lee H. Rosebush
   • Lowell M. Zeta

   Special Section on Pharmaceutical Compounding 30 December 2016 Pages: 270 - 278

4. Sterile Compounding Pharmacies: States That Do and Do Not Require Compliance With USP <797> Versus FDA 483s

   • Michelle Wilson

   Special Section on Pharmaceutical Compounding 30 December 2016 Pages: 279 - 303

5. A Paradigm Shift Towards Patient Involvement in Medicines Development and Regulatory Science: Workshop Proceedings and Commentary

   • Gitte Borup
   • Karin Friis Bach
   • Niels Westergaard

   Regulatory Science: Commentary 30 December 2016 Pages: 304 - 311

6. Trend Analysis of FDA Warning Letters Issued to Medical Products About Violations to Current Good Manufacturing Practices (CGMP) Between 2007 and 2014

   • Liqing Wang
   • Hang Zheng
   • He Sun

   Regulatory Science: Original Research 30 December 2016 Pages: 312 - 318

7. Regulatory Informatics Reveals Minimal Residual Disease Trends in Hematologic Malignancies

   • Elizabeth A. Rach
   • Shruti Kalra
   • Hsiao-Ling Hung

   Regulatory Science: Original Research 30 December 2016 Pages: 319 - 329

8. Improving Regulatory Education: Can We Reconcile Employers’ Expectations With Academic Offerings?

   • Daniela Drago
   • Sandra Shire
   • Ozgur Ekmekci

   Regulatory Science: Original ResearchOriginal Research 30 December 2016 Pages: 330 - 336

9. Challenges in the Ethical Review of Research Involving Complementary and Integrative Medicine

   • Jeffrey A. Cooper
   • David Borasky
   • Jeremy Sugarman

   Product Safety: Meeting Report 30 December 2016 Pages: 337 - 341

10. Implementing Benefit-Risk Assessment for the Periodic Benefit-Risk Evaluation Report

    • Margaret R. Warner
    • Anne M. Wolka
    • Rebecca A. Noel

    Product Safety: Original Research 30 December 2016 Pages: 342 - 346

11. Medicines Adaptive Pathways to Patients (MAPPs): A Story of International Collaboration Leading to Implementation

    • Duane Schulthess
    • Lynn G. Baird
    • Gigi Hirsch

    Global Perspectives: Commentary 30 December 2016 Pages: 347 - 354

12. Telaprevir-Induced Renal Adverse Events in Japanese Patients Reported in the PMDA Adverse Drug Reactions Reporting Database

    • Ayami Ichida
    • Hideyuki Motohashi
    • Yoshitaka Yano

    Global Perspectives: Original Research 30 December 2016 Pages: 355 - 360

13. Pharmaceutical Pricing and Reimbursement in Japan: For Faster, More Complete Access to New Drugs

    • Akane Takayama
    • Mamoru Narukawa

    Global Perspectives: Original Research 30 December 2016 Pages: 361 - 367

14. Review Experiences and Regulatory Challenges for Pharmaceutical Development in Japan Using a Quality-by-Design Approach

    • Kiyohito Kuno
    • Satoshi Toyoshima

    Global Perspectives: Original Research 30 December 2016 Pages: 368 - 374

15. Statistical Considerations for an Adaptive Design for a Serious Rare Disease

    • Kaushik Patra
    • Bruce A. C. Cree
    • Gary Cutter

    Statistics: Original Research 30 December 2016 Pages: 375 - 384

16. Global Innovators and Thought Leaders Across the Drug Information Industry to Gather in Philadelphia for DIA 2016

    Announcement 30 December 2016 Pages: v - v