Draft Guidance - Qualification Process for Drug Development Tools

• Date: October 28, 2010
• Source: www.fda.gov

This Draft guidance describes the qualification process for drug development tools (DDTs) intended 18 for potential use, over time, in multiple drug development programs. DDTs include, but are not 19 limited to, biomarkers and patient reported outcome (PRO) instruments. The guidance provides 20 a framework for interactions between CDER and DDT submitters.

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current  thinking on this topic . It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

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