Research and Drug Development

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All SubjectsResearch and Drug Development

Stakeholders interactions – Patients Affairs Staff

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsClinical DevelopmentEarly Access SupportPatient EngagementFDA Regulatory AdvicePatient Affairs StaffPatient SupportPatient Advice

At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

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Clinical Research Networks

Published by IRDiRC

Rare Disease Clinical Research NetworkClinical DevelopmentResearch and Drug DevelopmentNIHCRNClinical Trial ReadinessCinical Trial Design

The RDCRN is made up of multiple individual, Rare Disease Clinical Research Consortium (RDCRC) and a Data Management and Coordinating Center (DMCC). The RDCRCs are intended to advance the diagnosis, management, and treatment of rare diseases with a focus on clinical trial readiness

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FDA Qualification process – Drug Development Tools

Published by IRDiRC

EndpointResearch and Drug DevelopmentRegulatory AffairsClinical DevelopmentBiomarkerAnimal 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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