The Food and Drug Administration (FDA) issues a warning letter to Inova Genomics Laboratory of Falls Church, VA, for illegally marketing certain genetic tests that have not been reviewed by the FDA for safety and effectiveness.

Following issuance of the safety communication, the FDA reached out to several firms marketing pharmacogenetic tests with claims to predict how a person will respond to specific medications in cases where the relationship between genetic (DNA) variations and the medication’s effects has not been established. Most firms addressed the FDA’s concerns by removing specific medication names from their labeling, including promotional material and patient test reports.

Follow the agency press release for more details.


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