August 15th, 2014
Posted by Ken Walz
On July 31, 2014, the U.S. Food and Drug Administration announced its plans for regulation aimed at ensuring that certain tests used by healthcare professionals provide accurate, consistent and reliable results. First, the FDA issued a final guidance on the development, review and approval or clearance of companion diagnostics. Second, consistent with the requirements of the FDA Safety and Innovation Act of 2012 (FDASIA), the agency notified Congress of its intention to publish a proposed risk-based oversight framework for laboratory-developed tests (LDTs).
I recently spoke to new Popper and Company senior advisor, Michael Little, Ph.D., who recently retired from industry after a long career as a senior executive in the in vitro diagnostic (IVD) and companion diagnostic (CDx) industries. Following are excerpts from that interview.