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Food and Drug Act Health Care Law Products Liability

Genetic Labeling: Legal Uncertainty for Pharma Product Liability

The FDA’s recent approval of 23andMe’s direct-to-consumer genetic test to identify genes associated with 10 common diseases and disorders could result in a widespread expansion of patients armed with individualized health information. This expansion of genetic information in the hands of consumers potentially impacts regulatory and litigation issues for pharmaceutical companies.

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Customization of products and services is becoming increasingly popular. Today, we can individualize anything from a salad to a car. In fact, surveys from Bain & Co. and Deloitte have confirmed that over one-third of consumers are interested in personalized products.

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