FDA to revisit gene chip and multiplex assay guidance
This article was originally published in Clinica
In response to comments, the FDA has decided that its pioneering April 2003 draft guidance on gene chips and other multiplex assays was much too general and comprehensive. As a result, the agency is preparing two or more focused guidances. The first - on human genetic testing - will be released late this year or in early 2005, officials said in response to questions submitted by the American Association for Clinical Chemistry (AACC). Other guidances will come later, it said.
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