Critical path initiative

Both the EMEA and the EDA have recognised the need to streamline the drug development process in order to bring new medicines to patients more rapidly see for example FDA (2004) Critical Path Initiative . The FDA raise (FDA (2006) Critical Path Opportunities List ) a number of statistical issues that need to be resolved in order to help make the clinical trials process more efficient ... 

FDA s Critical Path to New Medicinal Products, also known as the Critical Path Initiative, aimed at networking clinical trials through integrative informatics... 

The declining economic efficiency of drug development led the FDA to try to identify root causes and potential solutions to this problem in its Critical Path Initiative, in which pharmacogenomics was recognized as one of the technologies that will lead to iimova-tion in the pharmaceutical industry (6). This has been followed by several advisories to industry, such as an opportunity for safe-harbor voluntary submission of genomic data by sponsors (50) and a series of collaborative workshops (7). 

Next Steps and Considerations for the Critical Path Initiative... 

Significant challenges lie ahead for the pharmaceutical community and for regulators to move to the desired state for pharmaceutical manufacturing in the 21st century. Nevertheless, important steps have already been taken. In addition, some of these challenges can be addressed through the FDA s Critical Path Initiative. 

Food and Drug Administration (2008) The FDA Critical Path Initiative. http //www. fda.gov/ oc/initiatives/criticalpath/... 

The FDA acknowledged that any new standards coming from the Critical Path Initiative should replace old standards, not constitute new requirements. As they noted, The goal of the Critical Path Initiative is to modernize standards, not create roadblocks. Some regulatory actions that could contribute to more efficient product development included ... 

Pharmaceutical productivity has been falling and costs have been rising. In 2004, the US FDA introduced the Critical Path Initiative to modernize drug development by introducing advancements in genomics, modeling and simulation, and advanced... 

Woodcock, J. and Woosley, R. (2008) The FDA critical path initiative and its influence on new drug development. Annual Review of Medicine, 59, 1-12. 

Regulatory Aspects of Modeling and Simulation (FDA Critical Path Initiative) 484... 

The Critical Path Initiative proposed by the Food and Drug Administration (1) has emphasized the need for informative knowledge-based drug development, and there has been much focus on the optimization of early drug development (2, 3). Phase 1 studies are critical in the overall process of drug development, and the need for the implementation of informative designs has been advocated in the literature (4-8). 

In 2004, FDA proposed the critical path initiative to develop a new product development toolkit (e.g., animal- or computer-based predictive models, biomarkers for safety and effectiveness, new clinical evaluation techniques, better manufacturing technologies) to improve the predictability and efficiency of the development process spanning laboratory concept to commercial product (http //www.fda.gov/oc/initiatives/ criticalpath). Three areas, where FDA s unique experience can facilitate improvement and streamlining, were identified ... 

Initially, FDA will develop a national Critical Path Opportunities List through extensive consultation with all pubhc and private stakeholders. In addition, FDA will make internal changes to intensify its ability to surface cracial issues and to support high-priority critical path research efforts. The critical path initiative is at an early stage, and doubtless will become an important component of FDA s overall strategy, greatly impacting the biopharmaceuti-cal industry. 

Reduced new drug approvals Low R D productivity 2004 Critical Path Initiative 0 Phase Clinical trials, biomarkers, and clinical trial design to speed np development... 

The most useful markers for changes in renal function and renal toxicity without special manipulation are clinical chemistry markers, including the newly identified set of seven identified by the Critical Path Initiative [5]. These can identify specific impaired function or toxicity (Table 7.7). 

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