1. New Horizons in Pediatric Drug Development

   • Stephen P. Spielberg
   • Ronald Portman

   Editorial 30 December 2015 Pages: 613 - 614

2. Enhancing Quality and Efficiency in Clinical Development Through a Clinical QMS Conceptual Framework: Concept Paper Vision and Outline

   • Ann Meeker-O’Connell
   • Maria Magdalena Borda
   • Leslie M. Sam

   Sponsored Special Section by TransCelerate BioPharma: Analytical Report Open access 30 December 2015 Pages: 615 - 622

3. Applying Regulatory Science to Develop Safe and Effective Medicines for Neonates: Report of the US Food and Drug Administration First Annual Neonatal Scientific Workshop, October 28–29, 2014

   • Martin Offringa
   • Jonathan M. Davis
   • Robert M. Nelson

   Special Section on Pediatrics: Analytical Report 30 December 2015 Pages: 623 - 631

4. Attention-Deficit Hyperactivity Disorder and Pharmacotherapy—Past, Present, and Future: A Review of the Changing Landscape of Drug Therapy

   • J. J. Connolly
   • J. T. Glessner
   • H. Hakonarson

   Special Section on Pediatrics: Review 30 December 2015 Pages: 632 - 642

5. Advancing Pediatric Psychiatry Research: Linking Neurobiological Processes to Novel Treatment and Diagnosis Through the Research Domain Criteria (RDoC) Project

   • Stacy Drury
   • Bruce Cuthbert

   Special Section on Pediatrics: Review 30 December 2015 Pages: 643 - 646

6. Best Practice Recommendations Regarding the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

   • Charles Thompson
   • Don Lombardi
   • Liza Squires

   Special Section on Pediatrics: Analytical Report 30 December 2015 Pages: 647 - 658

7. Regulatory and Funding Strategies to Develop a Safety Study of an Auditory Brainstem Implant in Young Children Who Are Deaf

   • Laurel M. Fisher
   • Laurie S. Eisenberg
   • Los Angeles Pediatric ABI Team

   Special Section on Pediatrics: Original Research 30 December 2015 Pages: 659 - 665

8. Food and Drug Administration Requirements for Clinical Studies in Pediatric Patients

   • Edward Tabor

   Special Section on Pediatrics: Analytical Report 30 December 2015 Pages: 666 - 672

9. iCAN: Providing a Voice for Children and Families in Pediatric Research

   • Hadleigh Thompson
   • Nicholas Frederico
   • Charles Thompson

   Special Section on Pediatrics: Review 30 December 2015 Pages: 673 - 679

10. Quantum of Effectiveness Evidence in FDA’s Approval of Orphan Drugs: Update, July 2010 to June 2014

    • Frank J. Sasinowski
    • Erika B. Panico
    • James E. Valentine

    Regulatory Science: Original Research 30 December 2015 Pages: 680 - 697

11. An Estimate of the Benefit-Cost Impact of the FDA Guidance on Data Monitoring Committees

    • Jonathan Seltzer

    Regulatory Science: Original Research 30 December 2015 Pages: 698 - 705

12. Identifying and Quantifying the Accuracy of Product Name Attribution of US-Sourced Adverse Event Reports in MedWatch of Somatropins and Insulins

    • Stella Stergiopoulos
    • Carrie A. Brown
    • Kenneth A. Getz

    Product Safety: Original Research 30 December 2015 Pages: 706 - 716

13. Topic of Timely Interest—Decision Criteria for Negative QT Assessment Using Exposure Response Analysis of Data From Early-Phase Clinical Studies: Letter to the Editor

    • Borje Darpo
    • Georg Ferber
    • Norman Stockbridge

    Product Safety: Letter to the Editor Open access 30 December 2015 Pages: 717 - 719

14. A Model Data Management Plan Standard Operating Procedure: Results From the DIA Clinical Data Management Community, Committee on Clinical Data Management Plan

    • Scott Brand
    • Diana Bartlett
    • Kristin Neff

    Product Development and Innovation: Original Research 30 December 2015 Pages: 720 - 729

15. Incentivizing Quality in the Manufacture of Pharmaceuticals: Industry Views on Quality Metrics and Ratings

    • Cesar Medina
    • Frances J. Richmond

    Product Development and Innovation: Analytical Report 30 December 2015 Pages: 730 - 738

16. Bowel Preparations for Colonoscopy: A Regulatory Perspective

    • Klaus Gottlieb
    • J. Rick Turner
    • Fez Hussain

    Product Development and Innovation: Analytical Report 30 December 2015 Pages: 739 - 744

17. Establishing Return-on-Investment Expectations for Patient-Centric Initiatives

    • Kenneth A. Getz

    Product Development and Innovation: Analytical Report 30 December 2015 Pages: 745 - 749

18. Implementing the Principle of the 3 Rs Through the Indian Pharmacopoeia

    • Shruti Rastogi
    • M. Kalaivani
    • G. N. Singh

    Global Perspectives: Review 30 December 2015 Pages: 750 - 755

19. Evaluation of an Adaptive Maximizing Design Study Based on Clinical Utility Versus Morphine for TRV130 Proof-of-Concept and Dose-Regimen Finding in Patients With Postoperative Pain After Bunionectomy

    • James A. Bolognese
    • Ruth Ann Subach
    • Franck Skobieranda

    Biostatistics: Original Research 30 December 2015 Pages: 756 - 766