Tag: FDA

Update on 23andMe and the FDA

On June 10, 2010, 23andMe received a letter from the Food and Drug administration (FDA) expressing the agency's view that our Personal Genome Service™ may be subject to FDA regulation.  We have responded to this letter and are in the process of scheduling a meeting with the agency for further discussions.  ...

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FDA Adds Boxed Warning to Plavix Label to Highlight Reduced Effectiveness of the Drug In Poor Metabolizers

The U.S. Food and Drug Administration (FDA) has updated the label information for the commonly used anti-clotting medication Plavix® (clopidogrel) to stress to physicians that patients carrying certain genetic variations may not receive the full benefit from the drug. Plavix reduces the chance a harmful ...

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FDA Updates Label for Commonly Used Blood Thinner to Include Dosing Recommendations Based on Genetics

Warfarin (Coumadin®) is a blood thinner given to people at high risk for the formation of blood clots due to conditions such as deep vein thrombosis, heart valve disease or replacement, and irregular heart beat. The drug is also given to prevent recurrence of pulmonary embolism, heart attack and stroke. If ...

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