IND
The FDA authorisation required before testing an experimental drug in humans.
Definition
An Investigational New Drug application is the submission a sponsor must make to the FDA before testing an experimental drug in humans in the US. The IND contains preclinical pharmacology and toxicology data, manufacturing information, and proposed clinical protocols. The FDA has 30 days to place a clinical hold; otherwise, dosing may begin.
See also
- Phase 1 trial — First-in-human study, primarily testing safety and pharmacokinetics in 20–100 participants.
- NDA — New Drug Application — the FDA submission required to market a new small-molecule drug in the US.
- BLA — Biologics License Application — the FDA submission required for biologics (proteins, antibodies, gene therapies).