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FDA’s Approach to Direct-to-Consumer Genetic Testing

Joanne Hawana talks about the rise in direct-to-consumer genetic testing and how FDA has adapted its regulatory approach to such tests over the past few years as it has become more comfortable with genetic testing and sequencing technologies.

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Author

Joanne S. Hawana counsels global Mintz clients on regulatory and distribution-related considerations for new FDA-regulated products. She also advises clients on the business impacts of new federal and state actions on food, drugs, cosmetics, electronic nicotine systems, and medical devices.