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Genetic Testing Enforcement Priorities

Holland & Knight LLP

FDA Warning Letter Marks Significant Shift in Enforcement of Laboratory Developed Tests

Holland & Knight LLP on

The U.S. Food and Drug Administration's (FDA) March 21, 2024, warning letter to Agena Bioscience Inc. (Agena), a genetic diagnostic test developer, generated a lot of immediate commentary among regulatory lawyers and...more

WilmerHale

FTC Calls Out Genetic Data as an Enforcement Priority

WilmerHale on

The Federal Trade Commission (FTC) recently published a post on their Business Guidance Blog discussing lessons learned from three enforcement actions against sellers of genetic testing products. These guidelines address...more

Womble Bond Dickinson

Current Trends and Real-World Best Practices in Healthcare Fraud Compliance

Womble Bond Dickinson on

Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...more

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