1. Guest Editors’ Note: Special Issue on Regulatory Affairs

   • David M. Cocchetto
   • Loren L. Miller
   • Roger Croswell

   OriginalPaper 31 December 2000 Pages: 657 - 658

2. The Regulatory Environment for the New Millennium

   • Steven F. Hoff

   OriginalPaper 31 December 2000 Pages: 659 - 672

3. Measuring the Pace of New Drug Development in the User Fee ERA

   • Kenneth I. Kaitin
   • Joseph A. DiMasi

   OriginalPaper 31 December 2000 Pages: 673 - 680

4. The Food and Drug Administration Modernization Act and the Food and Drug Administration: Metamorphosis or Makeover?

   • Christopher-Paul Milne

   OriginalPaper 31 December 2000 Pages: 681 - 692

5. OTCS 2000: Achievements and Challenges

   • R. William Soller

   OriginalPaper 31 December 2000 Pages: 693 - 701

6. Six Enduring Principles for Preparing NDAs

   • Michael J. Umen

   OriginalPaper 31 December 2000 Pages: 703 - 707

7. The Pharmaceutical Industry in the 21^st Century: Surviving in the E-Business Environment

   • Claudio P. Spiguel

   OriginalPaper 31 December 2000 Pages: 709 - 723

8. Breaking the Development Speed Barrier: Assessing Successful Practices of the Fastest Drug Development Companies

   • Kenneth A. Getz
   • Annick de Bruin

   OriginalPaper 31 December 2000 Pages: 725 - 736

9. Irinotecan—A Case Study for the Transition from Accelerated Approval to Traditional Approval

   • Daniel G. Mannix

   OriginalPaper 31 December 2000 Pages: 737 - 740

10. History and Accomplishments of the Inter-Company Collaboration for Aids Drug Development

    • David W. Barry
    • Linda M. Distlerath

    OriginalPaper 31 December 2000 Pages: 741 - 752

11. The Food and Drug Administration’s Fast Track Designation: Observations from the Initial Two Years of this Designation

    • David M. Cocchetto

    OriginalPaper 31 December 2000 Pages: 753 - 760

12. Regulatory Submissions: From Canda/Capla to 2002 and Beyond

    • Ross Raymond
    • Susan Galle
    • William Collom

    OriginalPaper 31 December 2000 Pages: 761 - 774

13. Transitioning to Electronic Publishing

    • Melissa A. Maynard

    OriginalPaper 31 December 2000 Pages: 775 - 777

14. One Module to Many Submissions: Generating Global Marketing Authorization Applications

    • Donna Morgan Murray
    • Susan M. Dansereau
    • Barbara R. Snyder

    OriginalPaper 31 December 2000 Pages: 779 - 792

15. Marketing Authorizations of Medicinal Products in the European Union: Past, Present, and Future

    • Guenter Hennings

    OriginalPaper 31 December 2000 Pages: 793 - 800

16. The New Attitude of the European Regulatory Authorities About Herbal Medicinal Products

    • Paolo M. Biffignandi
    • Lorella Carletto

    OriginalPaper 31 December 2000 Pages: 801 - 808

17. Pediatric Drug Development: The International Conference on Harmonization Focus on Clinical Investigations in Children

    • M. Renée Simar

    OriginalPaper 31 December 2000 Pages: 809 - 819

18. Carcinogenicity Testing of Pharmaceuticals in the European Union: A Workshop Report

    • Per Spindler
    • Jan-Willem van der Laan
    • Beatriz Silva Lima

    OriginalPaper 31 December 2000 Pages: 821 - 828

19. Development of Orphan Drugs in Japan: Effects of a Support System for Development of Orphan Drugs in Japan

    • Makoto Shiragami
    • Kiyohito Nakai

    OriginalPaper 31 December 2000 Pages: 829 - 837

20. Development of Orphan Drugs in Japan: Characteristics of Orphan Drugs Developed in Japan

    • Makoto Shiragami
    • Kiyohito Nakai

    OriginalPaper 31 December 2000 Pages: 839 - 846

21. Regulation of Clinical Trials in Israel: Recent Developments

    • Ran Frenkel
    • Mina Arinos
    • Esther Katz

    OriginalPaper 31 December 2000 Pages: 847 - 854

22. An Overview of an Initial Experience with a Medication Guide

    • Cynthia P. Chianese

    OriginalPaper 31 December 2000 Pages: 855 - 859

23. Regulation of Pharmaceutical Promotion in the Twenty-First Century

    • Louis A. Morris
    • Wayne L. Pines

    OriginalPaper 31 December 2000 Pages: 861 - 873

24. Regulatory Implications of Excipient Changes in Medicinal Products

    • Tom Sam

    OriginalPaper 31 December 2000 Pages: 875 - 894

25. Purity of Medicinal Products

    • Birgit Sølvkær Jensen
    • Lisbeth Ehlert Knudsen
    • Poul Vibholm Petersen

    OriginalPaper 31 December 2000 Pages: 895 - 902

26. International Conference on Harmonization Impurity Guidelines—The Industry Perspective

    • Guy Rousseau
    • Peter Jeffs

    OriginalPaper 31 December 2000 Pages: 903 - 907

27. Integrating Drug Supply Issues with Strategic Preclinical and Clinical Development

    • David F. Bernstein
    • Michael R. Hamrell

    OriginalPaper 31 December 2000 Pages: 909 - 917

28. Regulatory and Development Issues in the Demonstration of Therapeutic Equivalence for Multisource Biotech-Derived Pharmaceuticals

    • Robert L. Zeid

    OriginalPaper 31 December 2000 Pages: 919 - 959

29. A Survey of United Kingdom Independent Ethics Committees (Iecs): Acceptance Of And Readiness to Implement International Conference on Harmonization Good Clinical Practice

    • Angela V. Griffiths

    OriginalPaper 31 December 2000 Pages: 961 - 968

30. The Patient Advocate Perspective on Preparing for FDA Advisory Committee Presentations

    • Abbey S. Meyers

    OriginalPaper 31 December 2000 Pages: 969 - 973

31. Current Regulations and Practices for Adverse Event Reporting: Implications for Labeling

    • Michael R. Hamrell

    OriginalPaper 31 December 2000 Pages: 975 - 980

32. Outsourcing Regulatory Activities: How a Policy Can Drive Good Decisions

    • Suzanne Bates
    • Elizabeth Sloan

    OriginalPaper 31 December 2000 Pages: 981 - 985

33. Commentary: Outsourcing of Regulatory Activities: How A Policy Can Drive Good Decisions

    • Loren Miller

    OriginalPaper 31 December 2000 Pages: 987 - 989