Publication Library & Research Findings

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Impact Report
Cross-Functional Team Focus on Marketing is Key to Project Success
December 2000
Impact Report
User Fees Credited with 51% Drop in Average Approval Times since 1993
October 2000
Impact Report
Don't Turn Back the Clock on Drug Regulatory Reform
September 2000
Report
Price Trends for Prescription Pharmaceuticals: 1995-1999
Department of Health and Human Services
Joseph DiMasi
8/8/2000
Research Article
Measuring the Pace of New Drug Development in the User Fee ERA
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin, Joseph DiMasi
7/1/2000
Research Article
Breaking the Development Speed Barrier: Assessing Successful Practices of the Fastest Drug Development Companies
Therapeutic Innovation & Regulatory Science
Kenneth Getz
7/1/2000
Impact Report
Maine Enacts Drug Price Controls; 16 Other States Taking Similar Action
July/August 2000
Research Article
New Drug Approval Times and 'Therapeutic Potential' in Canada, Australia, Sweden and the United States During the Period 1992 to 1998
Canadian Journal of Clinical Pharmacology
Kenneth Kaitin
6/27/2000
Impact Report
Pharmaceutical Industry Innovation is More Dispersed Despite M&A Activity
June 2000
Impact Report
Influence of Pharmacoeconomics in Drug R&D Decisions is Growing
May 2000
Impact Report
Drug Firms Embrace Pediatric Study Program During first 2 Years of FDAMA
April 2000
Impact Report
European Approval of New Biotech Drugs Outpaces US Approval
March 2000
Research Article
The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee Era
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
1/1/2000
Impact Report
Effective Data Use Drives Portfolio Management and Global Strategies
January 2000
Impact Report
European and U.S. Approval Times for New Drugs Are Virtually Identical
November/December 1999
Research Article
The European Agency for the Evaluation of Medicinal Products' Centralized Procedure for Product Approval: Current Status
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
10/1/1999
Impact Report
Planning, Independence, Feedback Keep Global R&D Projects on Track
September/October 1999
Impact Report
Clinical Development Times for New Drugs Drop 18%, Reversing 12-Yr Trend
July/August 1999
Impact Report
Faster Approval of New Drugs Does Not Compromise US Public Safety
May/June 1999
Research Article
Global Drug Development and International Harmonization: The Emergence of China as a World Pharmaceutical Player
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
10/1/1998
Research Article
Drug Review in Canada: A Comparison with Australia, Sweden, the United Kingdom, and the United States
Drug Information Journal
Kenneth Kaitin
1/1/1998
Research Article
Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences
Drug Information Journal
Joseph DiMasi
12/30/1997
Research Article
The Prescription Drug User Fee Act of 1992 and the New Drug Development Process
American Journal of Therapeutics
Kenneth Kaitin
5/1/1997
Research Article
FDA Reform: Setting the Stage for Efforts to Reform the Agency
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
1/1/1997
Research Article
The New Drug Approvals of 1993, 1994, and 1995: Trends in Drug Development
American Journal of Therapeutics
Kenneth Kaitin
1/1/1997
Research Article
Factors Driving the Increased use of Outside Contractors in Drug Development
Clinical Research and Regulatory Affairs
Kenneth Getz
1/1/1997
Research Article
The Expanding Outside Clinical Services Contractor Marketplace
Clinical Research and Regulatory Affairs
Kenneth Getz
1/1/1997
Research Article
Recombinant Protein and Therapeutic Monoclonal Antibody Drug Development in the United States from 1980 to 1994
Clinical Pharmacology & Therapeutics
Joseph DiMasi
12/1/1996
Research Article
A New Look at Untied States Drug Development and Approval Times
American Journal of Therapeutics
Joseph DiMasi
9/1/1996
Research Article
An Analysis of Regulatory Review Times of Supplemental Indications for Already-Approved Drugs: 1989-1994
Drug Information Journal
Joseph DiMasi
4/1/1996
Research Article
The Prescription Drug User Fee Act of 1992. A 5-year Experiment for Industry and the FDA
Pharmacoeconomics
Kenneth Kaitin
2/1/1996
Research Article
Pharmaceutical Innovation in an Era of Reform
American Journal of Therapeutics
Kenneth Kaitin
9/1/1995
Research Article
Drug Safety Discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A Regulatory Perspective
Clinical Pharmacology & Therapeutics
Kenneth Kaitin
7/1/1995
Research Article
Success Rates for New Drugs Entering Clinical Testing in the United States
Clinical Pharmacology & Therapeutics
Joseph DiMasi
7/1/1995
Research Article
A Drug Lag Update
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
4/1/1995
Research Article
Trends in Drug Development Costs, Times, and Risks
Drug Information Journal
Joseph DiMasi
4/1/1995
Research Article
Managing Research Centers as a Portfolio of Strategic Resources
Therapeutic Innovation & Regulatory Science
Kenneth Getz
4/1/1995
Research Article
Research and Development Costs for New Drugs by Therapeutic Category. A Study of the US Pharmaceutical Industry
PharmacoEconomics
Joseph DiMasi
2/1/1995
Research Article
R&D Costs, Innovative Output and Firm Size in the Pharmaceutical Industry
International Journal of the Economics of Business
Joseph DiMasi
1/1/1995
Research Article
New Drug Development in the United States from 1963 to 1992
Clinical Pharmacology & Therapeutics
Joseph DiMasi
6/1/1994
Research Article
Risks, Regulation, and Rewards in New Drug Development in the United States
Regulatory Toxicology and Pharmacology
Joseph DiMasi
4/1/1994
Research Article
The New Drug Approvals of 1990, 1991, and 1992: Trends in Drug Development
The Journal of Clinical Pharmacology
Kenneth Kaitin
2/1/1994
Research Article
The Role of the Research-Based Pharmaceutical Industry in Medical Progress in the United States
The Journal of Clinical Pharmacology
Kenneth Kaitin
5/1/1993
Research Article
Are Initiatives to Speed the New Drug Approval Process Working?
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
7/1/1992
Research Article
Pharmaceutical Regulation in the European Community: Barriers to Single Market Integration
"Journal of Health Politics, Policy and Law"
Kenneth Kaitin
1/1/1992
Research Article
Rising Research and Development Costs for New Drugs in a Cost Containment Environment
PharmacoEconomics
Joseph DiMasi
1/1/1992
Research Article
Implementation of the Orphan Drug Act: 1983-1991
Food and Drug Law Journal
Joseph DiMasi
1/1/1992
Research Article
Cost of Innovation in the Pharmaceutical Industry
Journal of Health Economics
Joseph DiMasi
7/1/1991
Research Article
New Indications for Already-Approved Drugs: An Analysis of Regulatory Review Times
The Journal of Clinical Pharmacology
Joseph DiMasi, Kenneth Kaitin
3/1/1991
Research Article
The New Drug Approvals of 1987, 1988, and 1989: Trends in Drug Development
The Journal of Clinical Pharmacology
Kenneth Kaitin
2/1/1991