1. Pharmaceutical Ethics Comes to Life in Therapeutic Innovation & Regulatory Science

   • Wendy Lipworth

   Ethics Special Section: Guest Editorial 30 December 2015 Pages: 324 - 325

2. Medicines in Pregnancy Forum: Proceedings on Ethical and Legal Considerations

   • David B. Clemow
   • Martha R. Nolan
   • Lode Dewulf

   Ethics Special Section: Meeting Report 30 December 2015 Pages: 326 - 332

3. Confounding Issues in Cancer Progress—The Impact of Investor Requirements on Senior Management Compensation and Regulatory Decisions: Tivozanib and Aveo Pharmaceuticals

   • Josephine C. Babiarz
   • Francis Melaragni
   • Pranati Kuchimanchi

   Ethics Special Section: Analytical Report 30 December 2015 Pages: 333 - 341

4. Ethical Considerations for Increased Transparency and Reproducibility in the Retrospective Analysis of Health Care Data

   • Matthew D. Rotelli

   Ethics Special Section: Analytical Report 30 December 2015 Pages: 342 - 347

5. The Ethics Around Drug Labels and Generic Medicines

   • Richard Day
   • Wendy Lipworth
   • Narcyz Ghinea

   Ethics Special Section: Commentary 30 December 2015 Pages: 348 - 351

6. Expanded Access Programs: Ethical and Practical Considerations for Biopharmaceutical Sponsors

   • Mitchell Klopfenstein
   • Luann E. Van Campen
   • Timothy Garnett

   Ethics Special Section: Analytical Report Open access 30 December 2015 Pages: 352 - 358

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   • Narcyz Ghinea
   • Wendy Lipworth
   • Ian Kerridge

   Ethics Special Section: Analytical Report 30 December 2015 Pages: 359 - 363

8. Improving the Legitimacy of Medicines Funding Decisions: A Critical Literature Review

   • Jessica Pace
   • Sallie-Anne Pearson
   • Wendy Lipworth

   Ethics Special Section: Review 30 December 2015 Pages: 364 - 368

9. Focus on Health Literacy: Recommendations to Improve European Union Risk Management Plan Public Summaries

   • Anne Wolka
   • Katherine Simpson
   • Linda Neuhauser

   Policy: Original Research 30 December 2015 Pages: 369 - 376

10. Medication Guide Reading Behaviors and Attitudes Among Subjects With Migraine, Asthma, or COPD

    • Kristen B. Bibeau
    • Rachael L. DiSantostefano
    • David Hinds

    Policy: Original Research 30 December 2015 Pages: 377 - 386

11. Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the “Like”

    • William Jackson
    • Boas Park
    • Evelyn Hermes-DeSantis

    Policy: Original Research 30 December 2015 Pages: 387 - 391

12. Lessons Learned From Hundreds of Thorough QT Studies

    • Joanne Zhang
    • Huifang Chen
    • Norman Stockbridge

    Product Safety: Original Research 30 December 2015 Pages: 392 - 397

13. Choosing Appropriate Metrics to Evaluate Adverse Events in Safety Evaluation

    • Ying Zhou
    • Chunlei Ke
    • Steven Snapinn

    Product Safety: Review 30 December 2015 Pages: 398 - 404

14. Early Clinical Development Planning via Biomarkers, Clinical Endpoints, and Simulation: A Case Study to Optimize for Phase 3 Dose Selection

    • Bret Musser
    • James Bolognese
    • Nitin Patel

    Clinical Trials: Original Research 30 December 2015 Pages: 405 - 414

15. The Life Sciences Translational Challenge: The European Perspective

    • Richard W. Barker
    • Jack W. Scannell

    Product Development and Innovation: Review 30 December 2015 Pages: 415 - 424

16. Benefit-Risk Evaluation and Decision Making: Some Practical Insights

    • Michael W. Colopy
    • C. V. Damaraju
    • Zhong Yuan

    Product Development and Innovation: Meeting Report 30 December 2015 Pages: 425 - 433

17. Pre—Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products

    • Hong H. Vu
    • Anne R. Pariser

    Regulatory Science: Original Research 30 December 2015 Pages: 434 - 442

18. Treatment Outcomes of Nevirapine- Versus Efavirenz-Based Highly Active Antiretroviral Therapy Regimens Among Antiretroviral-Naive Adult Patients in Ethiopia: A Cohort Study

    • Muktar Sano Kedir
    • Desta Hiko Gemeda
    • Sultan Suleman

    Global Perspectives: Original Research 30 December 2015 Pages: 443 - 449