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New FDA Guidance Clarifies the DDT Qualification Process

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