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Genomics at FDA—U.S. Food and Drug Administration—Center for Drug Evaluation and Research (http://www.fda.gov/cder/genomics/default.htm)
It is well recognized that pharmacogenomics will play an important role in the development of pharmaceuticals and the individualization of treatments. This homepage is primarily not for oncologists but for people who are engaged with the regulatory issues involved in drug development. In this homepage, the U.S. Food and Drug Administrations (FDA) provides regulatory and related information on pharmacogenomics. The homepage consists of an overview, regulatory information, including guidances and concept papers, publications and presentation files by the FDA staffs, and so on.
In the overview, the FDA states the reason why these activities are necessary as: "Pharmacogenomics allows us to identify sources of an individual's profile of drug response and predict the best possible treatment option for this individual. The use of genomic information, accelerated by the sequencing of the human genome and the advent of new tools and technologies, has opened new possibilities in drug discovery and development. Consequently, regulatory science and regulations need to be set in place appropriately." The key document of this page is the one entitled "Stagnation or Innovation?—Challenge and Opportunity on the Critical Path to New Medical Products".
Activity by the FDA, such as publishing regulatory guidances etc., are not recognized as a field of ‘science’. However, someone has to be responsible for publicizing guidelines on how drug developers can gain market approval in compliance with national regulations in order that products resulting from innovative ideas or methods can be made publicly available and ultimately be of benefit to patients in clinical practice. It is also important that methodology be scientifically relevant, therefore, the activity of the FDA can be termed "regulatory science". It is now recognized that the U.S. FDA is the strongest leader of regulatory science in the world. Readers of this homepage can see that the FDA has a recognition and a responsibility for the proper utilization of pharmacogenomic data as a matter of regulatory science.
The contents in this homepage are concept papers: "Drug-Diagnostic Co-Development—Preliminary Draft Concept Paper" and "Drug Interaction Studies—Study Design, Data Analysis, and Implications for Dosing and Labeling: Preliminary Concept Paper." The reader can find out more about these in the "Regulatory Information". The information contained here is still at a very immature stage, but versions of future draft guidelines, concepts, points to consider and proposals written in these papers, may be worth following-up for translational researchers.
It is also remarkable in this page that the FDA states: "(T)he FDA has created a new training program for genomics for review staff, organizes and participates at numerous conferences and workshops and regularly publishes new considerations and findings in the scientific literature. The FDA also engages in several applied research projects to support and promote the translation of pharmacogenomics from basic research, drug discovery and development into clinical practice, focused on ensuring its proper employment to protect public health."
The FDA's methods are not always the best nor the most correct, however, we can see their struggle to step forward. We are confident that with no such struggle is there will be no innovation.
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