federal_register: 2014-00028

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2014-00028 Guidance for Industry on Qualification Process for Drug Development Tools; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Qualification Process for Drug Development Tools." This guidance describes the qualification process for drug development tools intended for potential use, over time, in multiple drug development programs. The guidance provides a framework for interactions between FDA and sponsors to support work towards qualification of an identified drug development tool and creates a mechanism for formal review of data to qualify the tool and ensure that the evaluation is comprehensive and reliable. 2014-01-07 2014 1 https://www.federalregister.gov/documents/2014/01/07/2014-00028/guidance-for-industry-on-qualification-process-for-drug-development-tools-availability https://www.govinfo.gov/content/pkg/FR-2014-01-07/pdf/2014-00028.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Qualification Process for Drug Development Tools." This guidance describes the qualification process for drug development tools intended for...

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