FDA Preparing Draft Document to Help Guide Microarray Data Consideration | GenomeWeb

The Food and Drug Administration expects to release within 60 days a draft guidance document on how to bring microarray data closer to the drug approval process.

“The agency wants to create an alternative path for this data, to remove the uncertainty, and encourage companies to explore it,” Lawrence Lesko, director of the FDA Office of Clinical Pharmacology and Biopharmaceutics, told BioArray News in a telephone interview.

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