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DNA FDA Approval

Womble Bond Dickinson

Liquid Biopsy and Next-Generation Sequencing Combined: Legal Implications?

Womble Bond Dickinson on

The Food and Drug Administration’s approval of Guardant Health’s Guardant360 CDx assay marks a new era for genetic mutation testing in cancer treatment. On August 7, 2020, the FDA approved the first diagnostic test that...more

Knobbe Martens

FDA Commissioner Plans to Create a Fast Track Approval Pathway for Certain Gene Therapies

Knobbe Martens on

During a speech on May 22, 2018 at the Alliance for Regenerative Medicine's Annual Board Meeting, Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that the FDA plans to alert companies that “certain...more

Carlton Fields

Genetic Testing – Unintended Consequences?

Carlton Fields on

The advent of 23andMe, ancestryDNA, and other direct-to- consumer genetic testing products permit patients, from the comfort of their own homes and personal computers, to identify and assess their unique risk of developing...more

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