Matt Herper, of Forbes, reports that FDA Commissioner Margaret Hamburg,, announced the FDA will be taking new steps to enforce regulations against certain diagnostic tests during her speech to recognize Richard Pazdur for his efforts in approving cancer drugs,. She says, “Advanced diagnostics such as these are the cornerstone of personalized medicine, and their development can only foreshadow the many advances on the horizon.” Hamburg accompanied that statement by revealing that not all diagnostic tests are made to perform at that level. LDT’s, or laboratory developed tests, are produced and used in the company’s own facilities but can be marketed without FDA premarket review. This was not a problem in the past because of the simplicity of the LDT’s, but now as they are becoming more complex the FDA is taking a greater interest. Hamburg’s speech did not discuss any specifics about future regulations and standards, but it is safe to say companies have heard the message she sent. Do you think new regulations will be beneficiary for diagnostic tests and LDT’s? Read the full article here.
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