Fixing How FDA Regulates Diagnostic Lab Tests

Roger D. Klein

Diagnostic laboratory tests play a central role in the implementation of precision medicine. It is essential that FDA regulation strike the right balance between protection of patient safety, and encouragement of advancement and innovation in testing. Read an original approach to FDA regulation that Professor David Hyman and I published in Investor’s Business Daily.

Roger D. Klein

Faculty Fellow, Center for Law, Science & Innovation

Sandra Day O'Connor College of Law


FDA & Health

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