May 12, 2010 at 7:03 p.m.
Filed under:
Health care
By Bruce Japsen and Sandra M. Jones | Walgreen Co. reversed a decision to carry genetic test kits in its stores after the U.S. Food and Drug Administration began looking into the supplier.
The Deerfield-based drugstore had planned to begin stocking its shelves with the Pathway Genomics home test kit on Friday, as reported by the Tribune yesterday. Walgreens’ decision was announced within hours after the FDA released an enforcement letter sent to San Diego-based Pathway giving it 15 days to respond to the agency’s request for information regarding its controversial genetic home test kit.
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May 12, 2010 at 5:37 p.m.
Filed under:
Health care,
Pharmaceuticals
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.
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