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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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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.