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Rachel Sachs (Academic Fellow)
Hastings Center Bioethics Forum
September 4, 2014

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From the article:

[...] [T]he FDA's proposal [to regulate laboratory-developed tests] ... could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of LDTs in current use. And by using an extensive system of carve-outs, the FDA is seeking to minimize potential harms for diagnostic innovation. Understanding these key portions of the FDA's disclosure to Congress is critical to a full policy discussion of the situation. [...]

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bioethics   fda   health law policy   public health