1. Update From the Field of Renal Sympathetic Denervation: A Focus on Safety Nomenclature Considerations

   • J. Rick Turner

   Editorial 30 December 2017 Pages: 664 - 668

2. Editorial Board Member’s Commentary: Commissioner Scott Gottlieb’s Predictable Imaginarium

   • Peter J. Pitts

   Editorial 30 December 2017 Pages: 669 - 670

3. Use of Qualitative Data to Support Content Validity of Performance-Based Cognitive Outcome Assessments

   • Chris J. Edgar

   Letter to the Editor 30 December 2017 Pages: 671 - 671

4. Implications of CRISPR-Based Germline Engineering for Cancer Survivors

   • Gregory Katz
   • Peter J. Pitts

   Commentary 30 December 2017 Pages: 672 - 682

5. Reference Limits for Outlier Analyses in Randomized Clinical Trials

   • Charles M. Beasley Jr.
   • Brenda Crowe
   • Paul S. Horn

   Clinical Trials: Original Research 30 December 2017 Pages: 683 - 737

6. Dose Finding in Late-Phase Drug Development

   • Lei Nie
   • Kyung Y. Lee
   • Rajeshwari Sridhara

   Clinical Trials: Original Research 30 December 2017 Pages: 738 - 743

7. Optimized Medical Product Regulation in Mexico: A Win-Win for Public and Economic Health

   • Mikel Andoni Arriola Peñalosa
   • Ricardo Cavazos Cepeda
   • Murray M. Lumpkin

   Global Perspectives: Original Research 30 December 2017 Pages: 744 - 750

8. The Common Pharmaceutical Market of the Eurasian Economic Union: A Regulatory Review

   • Raimond Lozda

   Global Perspectives: Review 30 December 2017 Pages: 751 - 755

9. Bone Mineral Density to Assess Pediatric Bone Health in Drug Development

   • Brian M. Maas
   • Jian Wang
   • Gilbert J. Burckart

   Product Development & Innovation: Original Research 30 December 2017 Pages: 756 - 760

10. Adaptive Seamless Design for Establishing Pharmacokinetic and Efficacy Equivalence in Developing Biosimilars

    • Ryuji Uozumi
    • Chikuma Hamada

    Product Development & Innovation: Original Research 30 December 2017 Pages: 761 - 769

11. Assessing Recall and Recognition for Important Safety Information in Digital Promotion for Pharmaceutical Products: Implications for Website Design

    • Michael Polster
    • Clifford Thumma
    • Nisith Kumar

    Product Safety: Original Research 30 December 2017 Pages: 770 - 779

12. An Innovative, Collaborative, and Strategic Approach to Proactively Evaluate and Update Drug Interactions Based on Prescribing Information of Newly Approved Medicinal Products

    • Ariel Porcalla
    • Nella Barshteyn
    • Mondira Bhattacharya

    Product Safety: Original Research 30 December 2017 Pages: 780 - 786

13. Impact of Expanded Access on FDA Regulatory Action and Product Labeling

    • Jonathan P. Jarow
    • Richard Moscicki

    Regulatory Science: Original Research 30 December 2017 Pages: 787 - 789