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

Keywords

Drug development, Medicine, Food and drug administration, Medical prescription, Pace

References

• New drug development in the United States from 1963 to 1992Santiago Bellés Medall — 1994
• The New Drug Approvals of 1996, 1997, & 1998: Drug Development Trends in The User Fee EraKenneth I. Kaitin, Elaine M. Healy — 1999
• Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor ConferencesJoseph A. DiMasi, Michael Manocchia — 1997
• Cost of innovation in the pharmaceutical industry.Joseph A. DiMasi, Ronald W. Hansen, Henry G. Grabowski — 1991
• The New Drug Approvals of 1996, 1997, and 1998: Drug Development Trends in the User Fee EraKenneth I. Kaitin, Elaine M. Healy — 2000

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• Drugs, the human genome, and individual-based medicine.Jay A. Glasel — 2002
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• Predicting Drug Target Proteins and Their PropertiesSimon Bull — 2015
• Patent as a Generator Rather than Inhibitor of Drug Accessibility in Developing Countries: a Critical Examination of India's Patent ModelGilat Ezra Pitkovsky — 2009
• The use of valuation models by European biotechnology analystsEmil Holmberg, Hans Jeppsson — 2011
• Industry funding of the FDA: effects of PDUFA on approval times and withdrawal ratesErnst R. Berndt, Adrian H. B. Gottschalk, Tomas Philipson — 2005
• The myth of the biotech revolution: An assessment of technological, clinical and organisational changeMichael M. Hopkins, Paul Martin, Paul Nightingale — 2007
• The socio-political roots of pharmaceutical uncertainty in the evaluation of 'innovative' diabetes drugs in the European Union and the US.Courtney Davis, John Abraham — 2011
• Sociology of pharmaceuticals development and regulation: a realist empirical research programme.John Abraham — 2008
• The Value of Improving the Productivity of the Drug Development ProcessJoseph A. DiMasi — 2012
• Risks in new drug development: Approval success rates for investigational drugsJoseph A. DiMasi — 2001
• Are development times for pharmaceuticals increasing or decreasing?Salomeh Keyhani, Marie Diener‐West, Neil R. Powe — 2006
• The economics of follow-on drug research and development: Trends in entry rates and the timing of development — The authors’ replyJoseph A. DiMasi, Cherie Paquette — 2005
• New drug development in the United States from 1963 to 1999Joseph A. DiMasi — 2001
• The pharmaceutical industry--prices and progress.F. M. Scherer — 2004
• Repurposing screens identify rifamycins as potential broad-spectrum therapy for multidrug-resistant Acinetobacter baumannii and select agent microorganisms.Brett A. Chromy, Maher Elsheikh, Tova Christensen — 2012
• Current Methodologies for Membrane Permeability AssessmentBeom-Soo Shin, Yu-Seok Youn, Seong‐Hoon Jeong — 2010
• Foreign subsidiary divestment decision process: The pharmaceutical industry experienceLuis M. Baquero, Teresa Longobardi — 2014
• Pharmaceuticalization of Society in Context: Theoretical, Empirical and Health DimensionsJohn Abraham — 2010
• The price of innovation: new estimates of drug development costs.Joseph A. DiMasi, Ronald W. Hansen, Henry G. Grabowski — 2003

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