is being presented by David Kern, Senior Director, RAC MBA and airs on Wednesday, April 20th, 2011. For more details, or to register please visit our site at www.fxconferences.com
If you are contemplating a companion diagnostics program, or if you already have such a program in place, you need to live in both the drug and diagnostic worlds. One key component to securing FDA approval – and staying in compliance – is understanding how in vitro diagnostics are regulated. Is your test a 510(K) or a PMA? What is the difference between an LDT and an IVD? Does FDA care about ISO standards and certification? This audio conference presentation reviews the current regulatory landscape for IVD tests, as well as lab-developed tests and companion diagnostics, focusing on the things pharma companies need to know.
