Critical Path Opportunities List

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 ... 

The issue of pediatric drug evaluation is considered again in Section 14.10 when discussing the FDA s March 2006 Critical Path Opportunities List Pediatrics is the sixth item on this list. 

The FDA recently released its Critical Path Opportunities List (see Section 14.10). One of six broad topic areas of opportunity listed is Harnessing Bioinformatics. Accordingly, the field of bioinformatics, which was introduced in Section 3.4, is discussed here in more detail. Given the importance of drug receptors throughout the book and the fact that drug receptors are typically proteins, the contribution of bioinformatics to our knowledge of proteins is of particular interest here. As Holmes et al. (2005) commented ... 

FDA s Critical Path Report and Critical Path Opportunities List... 

During the trial phase, the simulation model can be used as a vehicle to define an effective test protocol. As stressed in the American Food and Drug Administration Critical Path Opportunities List, clinical trial simulation can predict efficient designs for development programs that reduce the number of trials and patients, improve decisions on dosing, and increase informativeness [18]. 

FDA Critical Path Opportunities List, available at www.fda.gov/oc/initiatives/ criti-calpath/reports/opp list.pd T. 

Health Authorities like the FDA nowadays take innovation very seriously and intend to contribute in providing guidance to successful drug development. To illustrate this, the following quote from a recent Whitebook on Innovation/Stagnation is provided FDA intends to lead in the development of a national Critical Path Opportunities List... to bring concrete focus to the tasks that lie ahead. ... 

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. 

Food Drug Administration (2004) Critical Path Opportunity List (FDA Maryland). 

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