Meg Egan Auderset of Thomson Reuters explains the Final FDA guidance released in January 2014, which outlines the formal qualification process for drug development tools (DDTs), and offers a guide for interactions between entities proposing DDTs for qualification and the Center for Drug Evaluation and Research (CDER).
http://jforcs.com/jcs/wp-content/uploads/2014/04/New-FDA-Guidance-Clarifies-the-DDT-Qualification-Process.pdf