American Association for Clinical Chemistry
Better health through laboratory medicine
January 2009 Clinical Laboratory News: News from the FDA

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January 2009: Volume 35, Number 1

  C-Path Expands Partnerships of New Drug Therapies

The Critical Path Institute (C-PATH), a non-profit that works to streamline the development of new medicines by acting as a mediator between the FDA and private industry, has been awarded a $9 million investment grant from Science Foundation Arizona (SFAz). These funds will be used to improve testing methods that accelerate the development of treatments for major diseases, such as lung cancer, stroke, Alzheimer’s, and Parkinson’s disease. The grant is expected to have a continued impact on Arizona’s rise as a major state for biomedical and pharmaceutical research.

Genedata Extends Collaboration with FDA

Genedata announced a renewed agreement with FDA’s National Center for Toxicological Research for use of the Genedata Expressionist biomarker platform. Genedata Expressionist is a computational platform for biomarker discovery, which integrates transcriptomics, proteomics, and metabolomics data within a single software system. The platform provides a single point of access for all experimental data. Weida Tong, Director of the Center for Toxicoinformatics at the FDA said, “We have successfully applied Genedata Expressionist in a number of FDA projects, including the Critical Path project and the Liver Toxicity Knowledge Base project. Expressionist is an excellent system for monitoring the quality of gene expression data.”


MOU Signed Between FDA and USAMRIID

The FDA and the US Army Medical Research Institute of Infectious Diseases (USAMRIID) signed a memorandum of understanding agreeing to share information related to biological threats and diagnostic tests for biological agents in order to assist both parties in preparing for emergencies. As part of their agreement, USAMRIID will provide information on research and development efforts for diagnostics tests, as well as information and expertise on biothreat agents. The FDA agreed to provide feedback to USAMRIID in support of Department of Defense efforts to obtain FDA premarket approval, premarket clearance, or emergency use of authorization, for applications being developed by the Army.

FDA Teams Up with WebMD 

The FDA has teamed up with WebMD in an effort to expand consumers’ access to the agency’s health information. Consumers will now be able to access safety information on FDA-regulated products, receive public health alerts through the WebMD website, and learn how to report safety issues directly to the FDA. The FDA will also contribute Consumer Updates to WebMD The Magazine, a bimonthly publication reaching nearly nine million consumers. These new online resources can be viewed at Web MD and the FDA consumer website.