F.D.A Acts on Lab Test Developed In-House

The Food and Drug Administration announced on Thursday that it would start regulating medical laboratory testing, saying that tests used to make important treatment decisions must be vetted and validated before they go into use.

The decision, long in coming, has been fiercely opposed by some laboratories and pathologists, who have said that regulation by the agency is unnecessary and would significantly increase the cost and time needed to develop tests, stifling innovation and depriving patients of some vital tools. Read more.

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