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.

Authors
Faculty Fellow, Center for Law, Science & Innovation
Sandra Day O'Connor College of Law