FDA Takes a Bold Step Toward Laboratory Developed Test Regulation: How Labs and IVD Manufacturers Should Prepare for the Future
By EsqSocial Corporation 09/09/14
On July 31, 2014, the U.S. Food and Drug Administration ("FDA") announced plans to regulate laboratory developed tests ("LDTs"). In this Client Alert, we explore FDA's proposed regulatory framework for LDTs and discuss some of the many issues that...
By: Epstein Becker Green