FDA Asks Clinical Data to Discuss Regulatory Status of Its Tests | GenomeWeb
NEW YORK (GenomeWeb News) – The US Food and Drug Administration has asked Clinical Data to “discuss the nature and appropriate regulatory status” of the company’s diagnostic tests, Clinical Data said today.
 
Specifically, the firm and the FDA will discuss whether “any regulatory requirements apply, [and] the least burdensome ways that the company may fulfill them,” Clinical Data said.
 
The company said it plans to meet with the FDA “in the near future.”
 

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