Investigational New Drug Application
/ˌɪnvɛstəˈɡeɪʃənl nuː drʌɡ ˌæplɪˈkeɪʃən/
Definitions
- (n.) A regulatory submission to the FDA seeking permission to start clinical trials of a new drug in humans.
The pharmaceutical company filed an investigational new drug application before beginning clinical trials.
Forms
- investigational new drug application
- investigational new drug applications
Related terms
See also
Commentary
The term is strictly used in U.S. FDA regulatory context to denote the preclinical to clinical trial transition approval; precise drafting avoids conflation with marketing approvals.
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