Investigational New Drug (IND) application

Definition

An Investigational New Drug (IND) application is a request submitted to the FDA to obtain permission to start human clinical trials for a new drug. This application includes data from preclinical studies to ensure the drug's safety and efficacy.

5 Must Know Facts For Your Next Test

1. The IND application must contain information on animal pharmacology and toxicology studies, manufacturing information, and clinical protocols.
2. There are three types of INDs: Investigator IND, Emergency Use IND, and Treatment IND.
3. FDA reviews the IND application within 30 days to determine if the proposed study can proceed.
4. Gene therapy products must undergo rigorous preclinical testing before submitting an IND application.
5. The safety of trial participants is the primary concern in evaluating an IND application.

Review Questions

• What are the main components required in an Investigational New Drug (IND) application?
• How long does the FDA take to review an IND application?
• What types of studies must be conducted before submitting an IND for gene therapy?

Related terms

Clinical Trial Phases: The stages of testing that a new drug goes through in human subjects, including Phase I, II, III, and IV.

Preclinical Studies: Laboratory and animal studies conducted before human trials to assess safety and biological activity.

Biologics License Application (BLA): A request for permission to introduce a biologic product into interstate commerce, similar to but distinct from an NDA (New Drug Application).