FDA says final rules on good manufacturing practices and adverse event reporting for combination products could be out as early as this fall.
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An interactive look at recent executive-level company changes and promotions in the medical device and diagnostics industries.
The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.
Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.
