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FDA drug approval intervals from 1997 to 2006: analysis and comparison during information technology implementation

Author: Adams
Becker
Berndt
Bernstein
Borchardt
Carpenter
Center
Christopher M. Keller
Conover
DiMasi
DiMasi
Dranove
FDA Announces Standard Format that Drug Sponsors can use to Submit Drug Clinical Trial Data (2004)
FDA Awards up to $2.5 Billion to Modernize Information Technology over Ten Years - Cornerstone of 21st Century Bioinformatics Initiative (2008)
FDA drug approval time speeds up slightly (2002) 25 January. Available online at: http://ap.org/FDA_drug_approval_time_speeds_up_slightly_htm
FDA panel cites Shortfalls in Technology
FDA points to decline in drug review times in 1995 (1996)
FDA proposes first requirement for electronic submissions (2002) Available online at: www.fda.gov/fdac/special/newdrug/benefits.html
FDA shortens drug approval times in 1994
Feuerstein
Hartzband
John F. Kros
Kaitin
Kros
Meadows
Norusis
Novack
PDUFA
Pierson
Rawson
Reid
Publication venue: 'Inderscience Publishers'
Publication date: 01/01/2009
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