Guest Editors’ Note: Special Issue on Regulatory Affairs David M. CocchettoLoren L. MillerRoger Croswell OriginalPaper 31 December 2000 Pages: 657 - 658
The Regulatory Environment for the New Millennium Steven F. Hoff OriginalPaper 31 December 2000 Pages: 659 - 672
Measuring the Pace of New Drug Development in the User Fee ERA Kenneth I. KaitinJoseph A. DiMasi OriginalPaper 31 December 2000 Pages: 673 - 680
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
OTCS 2000: Achievements and Challenges R. William Soller OriginalPaper 31 December 2000 Pages: 693 - 701
Six Enduring Principles for Preparing NDAs Michael J. Umen OriginalPaper 31 December 2000 Pages: 703 - 707
The Pharmaceutical Industry in the 21st Century: Surviving in the E-Business Environment Claudio P. Spiguel OriginalPaper 31 December 2000 Pages: 709 - 723
Breaking the Development Speed Barrier: Assessing Successful Practices of the Fastest Drug Development Companies Kenneth A. GetzAnnick de Bruin OriginalPaper 31 December 2000 Pages: 725 - 736
Irinotecan—A Case Study for the Transition from Accelerated Approval to Traditional Approval Daniel G. Mannix OriginalPaper 31 December 2000 Pages: 737 - 740
History and Accomplishments of the Inter-Company Collaboration for Aids Drug Development David W. BarryLinda M. Distlerath OriginalPaper 31 December 2000 Pages: 741 - 752
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
Regulatory Submissions: From Canda/Capla to 2002 and Beyond Ross RaymondSusan GalleWilliam Collom OriginalPaper 31 December 2000 Pages: 761 - 774
Transitioning to Electronic Publishing Melissa A. Maynard OriginalPaper 31 December 2000 Pages: 775 - 777
One Module to Many Submissions: Generating Global Marketing Authorization Applications Donna Morgan MurraySusan M. DansereauBarbara R. Snyder OriginalPaper 31 December 2000 Pages: 779 - 792
Marketing Authorizations of Medicinal Products in the European Union: Past, Present, and Future Guenter Hennings OriginalPaper 31 December 2000 Pages: 793 - 800
The New Attitude of the European Regulatory Authorities About Herbal Medicinal Products Paolo M. BiffignandiLorella Carletto OriginalPaper 31 December 2000 Pages: 801 - 808
Pediatric Drug Development: The International Conference on Harmonization Focus on Clinical Investigations in Children M. Renée Simar OriginalPaper 31 December 2000 Pages: 809 - 819
Carcinogenicity Testing of Pharmaceuticals in the European Union: A Workshop Report Per SpindlerJan-Willem van der LaanBeatriz Silva Lima OriginalPaper 31 December 2000 Pages: 821 - 828
Development of Orphan Drugs in Japan: Effects of a Support System for Development of Orphan Drugs in Japan Makoto ShiragamiKiyohito Nakai OriginalPaper 31 December 2000 Pages: 829 - 837
Development of Orphan Drugs in Japan: Characteristics of Orphan Drugs Developed in Japan Makoto ShiragamiKiyohito Nakai OriginalPaper 31 December 2000 Pages: 839 - 846
Regulation of Clinical Trials in Israel: Recent Developments Ran FrenkelMina ArinosEsther Katz OriginalPaper 31 December 2000 Pages: 847 - 854
An Overview of an Initial Experience with a Medication Guide Cynthia P. Chianese OriginalPaper 31 December 2000 Pages: 855 - 859
Regulation of Pharmaceutical Promotion in the Twenty-First Century Louis A. MorrisWayne L. Pines OriginalPaper 31 December 2000 Pages: 861 - 873
Regulatory Implications of Excipient Changes in Medicinal Products Tom Sam OriginalPaper 31 December 2000 Pages: 875 - 894
Purity of Medicinal Products Birgit Sølvkær JensenLisbeth Ehlert KnudsenPoul Vibholm Petersen OriginalPaper 31 December 2000 Pages: 895 - 902
International Conference on Harmonization Impurity Guidelines—The Industry Perspective Guy RousseauPeter Jeffs OriginalPaper 31 December 2000 Pages: 903 - 907
Integrating Drug Supply Issues with Strategic Preclinical and Clinical Development David F. BernsteinMichael R. Hamrell OriginalPaper 31 December 2000 Pages: 909 - 917
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
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
The Patient Advocate Perspective on Preparing for FDA Advisory Committee Presentations Abbey S. Meyers OriginalPaper 31 December 2000 Pages: 969 - 973
Current Regulations and Practices for Adverse Event Reporting: Implications for Labeling Michael R. Hamrell OriginalPaper 31 December 2000 Pages: 975 - 980
Outsourcing Regulatory Activities: How a Policy Can Drive Good Decisions Suzanne BatesElizabeth Sloan OriginalPaper 31 December 2000 Pages: 981 - 985
Commentary: Outsourcing of Regulatory Activities: How A Policy Can Drive Good Decisions Loren Miller OriginalPaper 31 December 2000 Pages: 987 - 989