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Regulatory

Investigational New Drug (IND)

Definition

An Investigational New Drug application is a US regulatory submission that permits eligible clinical investigation of a drug under the IND framework; it is not marketing approval.

By PurePeptideHub Editorial Team · Updated . Educational source review; independent clinical review pending.

Application versus medicine

IND names a regulatory mechanism, not a chemical class. FDA describes the submission as including information on preclinical work, manufacturing and proposed clinical investigation. A compound can be under investigation without having demonstrated that it works for the intended condition.

References: [1]

How to interpret a trial claim

If a company cites an IND or a registered trial, check the sponsor, exact intervention, population and trial phase. A registry entry describes planned or ongoing work; results must be read separately. Permission to investigate does not turn a vendor’s similarly named product into the studied medicine.

Why product-specific examples age quickly

Regulatory status changes over time and can differ between countries, products and indications. Use a dated official record for a specific drug instead of treating an old list of investigational compounds as current approval guidance.

Sources and further reading

  1. FDA: Investigational New Drug application

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