Publication Library & Research Findings

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Research Article
The Cost of Institutional Review Boards in Academic Medical Centers
The New England Journal of Medicine
Kenneth Getz
4/28/2005
Impact Report
Protein Therapeutic Success Rates Increase With Biotech Advances
March/April 2005
Research Article
Setting the Record Straight: Response to the Light and Warburton Rejoinder
Joseph DiMasi
1/1/2005
Impact Report
Decline in Drug Approvals is Driving Industry, FDA to Enhance Efficiency
January/February 2005
Impact Report
CRO Contribution to Drug Development is Substantial and Growing Globally
January/February 2006
Research Article
The Regulation and Approval of New Drugs in China
Drug Information Journal
Kenneth Kaitin
12/30/2004
Report
Assessing Claims About the Cost of New Drug Development: A Critique of the Public Citizen and TB Alliance Reports
Journal of Health Economics
Joseph DiMasi
11/1/2004
Impact Report
Incremental R&D Creates Safer, More Effectives Drugs & Fosters Competition
November/December 2004
Commentary
Looking Back, Looking Forward
Drug Information Journal
Kenneth Kaitin
10/1/2004
Impact Report
Cost Issues Increasingly Drive US Formulary and Clinical Guidelines
September/October 2004
Research Article
Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals
Annals of Internal Medicine
Kenneth Getz
8/17/2004
Research Article
R&D Costs and Returns by Therapeutic Category
Drug Information Journal
Joseph DiMasi
7/1/2004
Impact Report
FDA Requested Postmarketing Studies in 73% of Recent New Drug Approvals
July/August 2004
Commentary
Patents and R&D Incentives: Comments on the Hubbard and Love Trade Framework for Financing Pharmaceutical R&D
"W.H.O. Commision on Intellectual Property Rights, Innovation, and Public Health (CIPIH)"
Joseph DiMasi
6/25/2004
Research Article
Going Global
Applied Clinical Trials
Mary Jo Lamberti
6/1/2004
Impact Report
Therapeutic Class a Critical Determinant of Drug Development Time & Cost
May/June 2004
Impact Report
Faster Review, Longer Response Time Mark New EU Biopharmaceuticals
March/April 2004
Research Article
The Economics of Follow-On Drug Research and Development
Pharmacoeconomics
Joseph DiMasi
1/1/2004
Impact Report
High Cost of Drug Development Spurs New Ways to Assess and Manage Risk
January/February 2004
Impact Report
FDA's Fast Track Initiative Cut Total Drug Development Times By 3 Years
November/December 2003
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