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Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01) Clinical Trials Not Required

Published by NIH

Medicine DevelopmentNatural History StudyRare diseases

The purpose of this funding opportunity announcement (FOA) is to support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.

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PudChem

Published by NIH

Chemical StructurePatentPudChemSafetySmall MoleculeToxicology

PubChem is an open chemistry database at the National Institutes of Health (NIH). PubChem mostly contains Small Molecules, but also larger molecules such as nucleotides, carbohydrates, lipids, peptides, and chemically-modified macromolecules.It collects information on Chemical Structures, identifiers, chemical and physical properties, biological activities, patents, health, Safety, toxicity data, and many others

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The Assay Guidance Manual

Published by NIH

Drug Discovery GuidelineDrug RepurposingNCATSNIHResearch and Drug DevelopmentSmall MoleculeTarget Validation Drug Development

This manual is a comprehensive resource for early drug discovery, providing guidelines for developing therapeutic hypotheses, validating targets and pathways, and establishing proof of concept criteria. It includes analyses of costs at various stages of drug development. The content encompasses critical decision-making points in New Chemical Entity (NCE) development, exploratory Investigational New Drug (IND) processes, and orphan drug designation. Furthermore, it delves into Drug Repurposing and drug delivery technologies, making it an invaluable guide for professionals initiating new drug discovery and development programs.

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