Dunne to Address Litigation Risks Related to Molecular Diagnostics at ABA Workshop

Pharmaceutical & Medical Device Partner Debra Dunne will join a distinguished panel in a session during an October 9, 2014, ABA Section of Litigation CLE workshop in Austin, Texas. Titled “Regulation of Molecular Diagnostics and Potential Litigation Issues,” the panel discussion will focus on the Food & Drug Administration’s existing bifurcated regulatory pathway for molecular diagnostic tests, including laboratory developed tests, and draft agency guidance meant to simplify the requisite steps for approval into a risk-based process.