Abbott Labs said the FDA today approved its new diagnostic test that allows for earlier detection of HIV. Get the full story »
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FDA gives maker of gene test kit a deadline to respond
By Bruce Japsen and Sandra M. Jones | The U.S. Food and Drug Administration has given San Diego-based Pathway Genomics 15 days to respond to the agency’s request for information regarding its controversial genetic home test kit.
In a letter released this evening, FDA Deputy Director for Patient Safety and Product Quality James Woods said the agency has been “unable to identify any Food and Drug Administration clearance or approval number” for the product.
