Genomic Data and the FDA

Edward R. Winstead, Genomes and Medicine–Part One, Genome News Network, September 19, 2003.

A brief analysis of how the FDA is dealing with the use of new forms of data, such as microarray data, in regulatory submissions. "The newness is a problem and a challenge. There are no universal standards for analyzing and reporting microarray or other genomic data." 

UPDATE: The FDA recently issued guidance for the submission of pharmacogenomic data.  See the press release here. 
One notable graf from the press release:

This is FDA’s first step towards integration of this new field into the process of demonstrating that new drugs are safe and effective, and thus the regulatory guidance is intended to facilitate this integration. This guidance is intended to ensure that evolving regulatory policies and study designs are based on the best science; provide public confidence in this new field where scientifically appropriate; facilitate the use of such tests during drug development; and clarify for industry what types of pharmacogenomic data to submit to FDA.

"Using genomic testing to guide drug therapy will constitute a significant shift from the current practice of population-based treatment towards "fine-tuning" individual therapy," said Janet Woodcock, FDA’s Director of the Center for Drug Evaluation and Research.

October 9, 2003 | Filed Under standards 

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