Zdrowie i gospodarka · 25.10.2010
Draft Guidance for Industry on Qualification Process for Drug Development Tools; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Qualification Process for Drug Development Tools." This draft guidance describes the qualification process for drug development tools (DDTs) intended for potential use, over time, in multiple drug development programs. The draft guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and DDT sponsors to support work towards qualification of an identified DDT and creates a mechanism for formal review of data by CDER to qualify the DDT and ensure that the evaluation is comprehensive and reliable.