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Drugs

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Guidance Documents (DDT)

Guidance for Industry: Use of Histology in Biomarker Qualification Studies (PDF - 298KB) (December 2011)
Guidance for Industry: Qualification Process for Drug Development Tools (PDF - 189KB) (October 2010)
International Conference on Harmonization: Guidance on E16 Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure, and Format of Qualification Submissions (PDF - 111KB) (August 2011)
Guidance for Industry: Patient Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims (PDF - 295KB) (December 2009)
Guidance for Industry: Animal Models – Essential Elements to Address Efficacy Under the Animal Rule (PDF - 135KB) (January 2009)

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