Publication Library & Research Findings

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Research Article
The New Drug Approvals of 1999, 2000, and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992
Therapeutic Innovation & Regulatory Science
Kenneth Kaitin
10/1/2003
Research Article
Canadian and US Drug Approval Times and Safety Considerations
Annals of Pharmacotherapy
Kenneth Kaitin
10/1/2003
Commentary
From the Editor In Chief: A Tribute to Dr. Louis C. Lasagna: 1923 - 2003
Drug Information Journal
Kenneth Kaitin
10/1/2003
Impact Report
Switching Drugs From Prescription to OTC Status On Rise in US and EU
September/October 2003
Impact Report
CROs Provide Gateway to Worldwide Clinical Trial Recruitment Efforts
July/August 2003
Impact Report
Post-Approval R&D Raises Total Drug Development Costs to $897 Million
May/June 2003
Impact Report
Biopharmaceutical Product Approval Times Dropped 21% Since the 1980s
March/April 2003
Impact Report
Increased Pressure On Drug Industry is Leading to Greater Focus on Japan
January/February 2003
Commentary
Beyond the Blockbuster
Pharmaceutical Executive
Kenneth Kaitin, Robert Franco
11/1/2002
Impact Report
Approval Times for New Drugs Fell By More Than a Year During PDUFA
November/December 2002
Research Article
The Price of Innovation: New Estimates of Drug Development Costs
Journal of Health Economics
Joseph DiMasi
10/8/2002
Impact Report
Tufts CSDD Quantifies Savings From Boosting New Drug R&D Efficiency
September/October 2002
Impact Report
Approval Times for Priority-Reviewed New Drugs Declined Under PDUFA
July/August 2002
Impact Report
Biotechnology Has Become Vital to Orphan Product Development
May/June 2002
Editorial
From the Editor-In-Chief: Regulatory Reform at a Crossroads
Drug Information Journal
Kenneth Kaitin
4/1/2002
Impact Report
Disease Management Cuts Inpatient Cost Via Greater Drug Spending
March/April 2002
Book Chapter
Uncertainty in Drug Development: Approval Success Rates for New Drugs
"Clinical Drug Trials and Tribulations, Revised and Expanded"
Joseph DiMasi
1/1/2002
Research Article
Returns on Research and Development for 1990s New Drug Introductions
PharmacoEconomics
Joseph DiMasi
1/1/2002
Impact Report
Portfolio Analysis Links Strategy to Operations, Improves Performance
January/February 2002
Impact Report
Biotech Products Proliferate, But Total Development Times Lengthen
November/December 2001
Impact Report
Study Measures Single Controlled Trial Use in New Drug Development
September/October 2001
Impact Report
Biopharmaceutical R&D Involves Fewer Studies Than Pharmaceuticals
July/August 2001
Commentary
New Drug Development in the United States from 1963 to 1999
Clinical Pharmacology & Therapeutics
Joseph DiMasi
5/2/2001
Impact Report
Pharmaceutical Firms Making Quicker Decisions on Compounds in R&D
May/June 2001
Impact Report
Tufts Center Survey Describes Disease Management Practice in the US
March/April 2001
Research Article
Risk in New Drug Development: Approval Success Rates for Investigational Drugs
Clinical Pharmacology & Therapeutics
Joseph DiMasi
2/26/2001
Research Article
The ALPHA Project: Establishing Consensus and Prioritsation of Global Community Recommendations to Address Major Challenges of Lupus Diagnosis, Care, Treatment and Research
Lupus Science & Medicine
Kenneth Getz
2/9/2001
Research Article
Emerging Role of Pharmacoeconomics in the Research and Development Decision-Making Process
PharmacoEconomics
Joseph DiMasi
1/1/2001
Impact Report
FDA's Fast Track Program Results in 62% Approval Rate After First 3 Years
January/February 2001
Research Article
New Drug Innovation and Pharmaceutical Industry Structure: Trends in the Output of Pharmaceutical Firms
Therapeutic Innovation & Regulatory Science
Joseph DiMasi
12/31/2000
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