FDA & Regulatory
Investigational New Drug Application
An Investigational New Drug (IND) application is the request a sponsor files with the FDA to begin human clinical trials. Clearance of the IND allows a candidate to move from preclinical work into Phase 1.
- Category
- FDA & Regulatory
- Abbreviation
- IND
Prepared research question
How does Investigational New Drug Application affect the view of a biotech company in practice?
Traceable citations · Unknowns marked
An Investigational New Drug (IND) application is the request a sponsor files with the FDA to begin human clinical trials. Clearance of the IND allows a candidate to move from preclinical work into Phase 1.
Related terms
From term to thesis rule
Investigate how Investigational New Drug Application changes a biotech thesis
Define when Investigational New Drug Application should count, block, or trigger a deeper check; BioSniper will compile that logic against available evidence.