Disease or Translational Resources

In this section you will have the opportunity to explore information regarding:
Patient registries,
Natural history,
Patients’ information as organizations, toolkits for patients, new-born screening programs, undiagnosed diseases programs (UDPs), EU planned cross-border treatment
Target Patient Value Profile
Databases/Tools (ODDG)
Networks
Biobanks
Biomarkers (Development, guidelines, validation, qualification, genomic, cancer, pain therapeutics)

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  2. Research and Drug Development
  3. Disease or Translational Resources
All SubjectsRegulatory Affairs

AMED – Initiative on Rare and Undiagnosed Diseases

Published by IRDiRC

Regulatory AffairsOrphan Drug Development GuidelineAgency For Medical Research and DevelopmentInitiative on Rare DiseaseGenetic Analysis

Japan Agency for Medical Research and Development (AMED) leads the Initiative on Rare and Undiagnosed Diseases (IRUD) program. The program provides patients across Japan suffering from undiagnosed diseases with a diagnostic strategy that involves genetic analysis

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FDA Qualification process – Drug Development Tools

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEndpointBiomarkerAnimal ModelQualification ProcessDrug Development ToolCenter for Drug Evaluation and Research

This guidance provides a framework for interactions between the Center for Drug Evaluation and Research (CDER) and the entity proposing the DDT for qualification (the submitter). It also explains the kinds of data that should be submitted to support qualification of a DDT and creates a mechanism for CDER’s formal review of the data to ultimately qualify the DDT.

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