1. Introduction: PhRMA’s Best Practices Initiative on FDA’s Good Review Management Practices

   • J. Michael Maher

   PhRMA Best Practices 30 December 2008 Pages: 1 - 2

2. Best Practices for Communication between FDA and Applicants during the NDA Review Cycle: A PhRMA White Paper

   • David M. Cocchetto
   • Jennifer L. Stotka
   • Donna Peterson

   PhRMA Best Practices 30 December 2008 Pages: 3 - 8

3. Best Practices for Special Protocol Assessment

   • Linda Carter
   • Cathie Schumaker

   PhRMA Best Practices 30 December 2008 Pages: 9 - 12

4. Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper

   • David M. Cocchetto
   • Thomas H. Hassall
   • Jennifer L. Stotka

   PhRMA Best Practices 30 December 2008 Pages: 13 - 21

5. A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments

   • Michelle Folz
   • Mark Bokelman
   • Jennifer L. Stotka

   PhRMA Best Practices 30 December 2008 Pages: 23 - 26

6. Vector Analysis to Detect Hepatotoxicity Signals in Drug Development

   • Donald C. Trost
   • James W. Freston

   Continuing Education 30 December 2008 Pages: 27 - 34

7. Changes in Warnings and Contraindications in Prescription Drug Labeling Due to Liver Toxicity

   • Yeong-Liang Lin

   Preclinical 30 December 2008 Pages: 35 - 44

8. Assessing the Performance of the EMEA’s Centralized Procedure: A Comparative Analysis with the US FDA

   • Laura B. Faden
   • Kenneth I. Kaitin

   Regulatory 30 December 2008 Pages: 45 - 56

9. Two Hot Spots (Black Holes?) in the Regulatory Galaxy: Proactive Safety and eSubmissions—A Call for Contributions

   • E. Gaussens
   • S. Daniel
   • P. Banes

   Regulatory 30 December 2008 Pages: 57 - 64

10. Handbook of Pharmaceutical Public Policy

    • Paul Stang

    Book Review 30 December 2008 Pages: 65 - 66

11. Survey of Medical Liaison Practices No. 2: Assessing Training Techniques and Demonstrating Value of Medical Liaisons

    • Christopher M. Marrone
    • J. Lynn Bass
    • Craig Klinger

    Medical Information 30 December 2008 Pages: 67 - 80

12. On the Applications of Fisher’s Least Significant Difference (LSD) Procedure in Three-Arm Clinical Trials with Survival Endpoints

    • Shifting Liu
    • Dongsheng Tu

    Biostatistics 30 December 2008 Pages: 81 - 91

13. International Symposium on Adaptive Clinical Trial Designs

    • Christian Gluud
    • Anders Dejgaard
    • Per Spindler

    Proceedings 30 December 2008 Pages: 93 - 97