Published by FDA-NIH Biomarker Working Group
EndpointResearch and Drug DevelopmentClinical Trial DesignBiomarkerA biomarker discovery and validation guideline for clinical trial design and the drug development.
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Biomarker DiscoveryResearch and Drug Development Disease or Translational Resource BiomarkerPain Therapeutic BiomarkerChronic PainBiomarker ValidationRegulatory IssueThis article outlined the NIH initiative, Helping to End Addiction Long-term (HEAL). A trans-agency effort to provide scientific solutions to stem the opioid crisis. One component of the initiative is to provide guidance on biomarker discovery and rigorous validation to accelerate high-quality clinical research into neurotherapeutics and pain.
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PreclinicalResearch and Drug DevelopmentBiomarkerDrug Development ToolQualification BiomarkerRegulatory QualificationAn overview of the biomarker qualification process that provides information on current evidentiary considerations. It also provides new information on the evolution of the role that preclinical qualification plays in clinical qualification of biomarkers and the novel approaches that are being utilized to improve the process
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EndpointResearch and Drug DevelopmentRegulatory AffairsClinical DevelopmentCenter for Drug Evaluation and ResearchBiomarkerAnimal ModelQualification ProcessDrug Development ToolThis 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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