The FDA Seeks to Regulate New Types of Genetic Tests

In September, The New York Times reported that the Food and Drug Administration was taking steps to regulate a new category of complex diagnostic tests expected to play a growing role in tailoring medical treatments to specific patients. The new policy was published only as draft guidelines open for public comment, so the regulation has not yet become law and there is still time to voice any concerns you or your lab may have. The FDA already requires approval of diagnostic test kits that are...
;