1. Multifaceted Paths Toward Advancing Regulatory Science

   • Stephen P. Spielberg

   Editorial 30 December 2015 Pages: 465 - 465

2. How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs: Some Illustrative Examples

   • Mark Geanacopoulos
   • Ruth Barratt

   Regulatory Science: Review 30 December 2015 Pages: 466 - 472

3. Monitoring and Evaluating the Effect of Regulatory Action: Some Recent Case Studies

   • Andrew Thomson
   • Wilhelmine Hadler Meeraus
   • Rafe Suvarna

   Regulatory Science: Analytical Report 30 December 2015 Pages: 473 - 482

4. APEC Workshop Report of Good Review Practices on Medical Products

   • Hsien-Yi Lin
   • Steven Jun-Yi Chen
   • Li-Ling Liu

   Regulatory Science: Meeting Report 30 December 2015 Pages: 483 - 492

5. Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study

   • Helen W. Sullivan
   • Amie C. O’Donoghue
   • Kathryn J. Aikin

   Policy: Original Research 30 December 2015 Pages: 493 - 502

6. A Descriptive Evaluation of Prescriber Perceptions and Experience With Risk Evaluation and Mitigation Strategy (REMS) Programs in an Integrated Health Care System

   • Nazia Rashid
   • T. Craig Cheetham
   • Raymond J. Coghlan

   Product Safety: Original Research 30 December 2015 Pages: 503 - 510

7. Cardiac Safety Research Consortium (CSRC): Cardiovascular Safety and Adverse Event Case Report Forms

   • Mary Elizabeth Sabol
   • John Finkle
   • Richard Oh

   Product Safety: Commentary 30 December 2015 Pages: 511 - 513

8. Drug Safety and the Cost of Monitoring: The Role of REMS in Risk Management

   • Mark Slomiany
   • Rema Bitar
   • Mahmud Hassan

   Product Safety: Original Research 30 December 2015 Pages: 514 - 523

9. A Method of Addressing Proprietary Name Similarity for US Prescription Drugs

   • Melissa D. Stockbridge
   • Kellie Taylor

   Product Safety: Review 30 December 2015 Pages: 524 - 529

10. Current Trends in Personalized Medicine and Companion Diagnostics: A Summary From the DIA Meeting on Personalized Medicine and Companion Diagnostics

    • Marilyn Tsourounis
    • Jeffrey Stuart
    • Joseph Barone

    Product Development and Innovation: Review 30 December 2015 Pages: 530 - 543

11. What Defines Good Quality in a Clinical Study Report?

    • Thomas M. Schindler

    Clinical Trials: Analytical Report 30 December 2015 Pages: 544 - 546

12. Assessment of the e-Answers Initiative, a New Model for Response by Email to Scientific Information Requests Carried Out by the Medical Information Service of Novartis Pharmaceuticals in Spain: Results of an Internal Satisfaction Survey

    • Clara Amat
    • Anastasia Sarycheva
    • Elisenda Berge

    Global Perspectives: Original Research 30 December 2015 Pages: 547 - 552

13. An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009–2014: A Focus on Benefit-Risk and Clinical Development Conditions

    • Dominik Sawicki-Wrzask
    • Mikael Thomsen
    • Ole J. Bjerrum

    Global Perspectives: Original Research 30 December 2015 Pages: 553 - 559

14. An Evaluation of the Efficiency of the Gulf Cooperation Council’s Centralized Procedure by the Gulf Regulatory Authorities and Pharmaceutical Companies: Recommendations for an Improved Model

    • Mohamed H. Al-Rubaie
    • Sam Salek
    • Stuart Walker

    Global Perspectives: Analytical Report 30 December 2015 Pages: 560 - 568

15. Statistical Challenges in the Analyses of Bone Mineral Density in Pediatric Populations

    • Phillip Dinh

    Special Populations: Analytical Report 30 December 2015 Pages: 569 - 575

16. Comparison of Approved Dosages for Pediatric and Adult Populations Based on US Labeling Information

    • Keizo Hanada
    • Masayuki Kaneko
    • Mamoru Narukawa

    Special Populations: Original Research 30 December 2015 Pages: 576 - 583

17. Choosing Appropriate Estimands in Clinical Trials

    • Ann-Kristin Leuchs
    • Jörg Zinserling
    • Norbert Benda

    Biostatistics: Analytical Report 30 December 2015 Pages: 584 - 592

18. Sample Size and the Precision of the Confidence Interval in Meta-analyses

    • Xiaofeng Steven Liu

    Biostatistics: Analytical Report 30 December 2015 Pages: 593 - 598

19. Risk Minimization Activities and Measures of Effectiveness: A New Approach

    • Rudolph Valentino

    Letters to the Editor Open access 30 December 2015 Pages: 599 - 600

20. Choosing Appropriate Estimands in Clinical Trials (Leuchs et al): Letter to the Editor

    • Andrew Garrett

    Letters to the Editor 30 December 2015 Pages: 601 - 601