The FDA critical path initiative and its influence on new drug development.

Abstract:

:Societal expectations about drug safety and efficacy are rising while productivity in the pharmaceutical industry is falling. In 2004, the US Food and Drug Administration introduced the Critical Path Initiative with the intent of modernizing drug development by incorporating recent scientific advances, such as genomics and advanced imaging technologies, into the process. An important part of the initiative is the use of public-private partnerships and consortia to accomplish the needed research. This article explicates the reasoning behind the Critical Path Initiative and discusses examples of successful consortia.

journal_name

Annu Rev Med

authors

Woodcock J,Woosley R

doi

10.1146/annurev.med.59.090506.155819

subject

Has Abstract

pub_date

2008-01-01 00:00:00

pages

1-12

eissn

0066-4219

issn

1545-326X

journal_volume

59

pub_type

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