Investigational New Drug Application (IND)
INDAn FDA submission required before a new drug can be administered to humans in clinical trials. Contains preclinical data, manufacturing information, and the clinical protocol.
例
- 30-day safety review
- IND-enabling studies
- Treatment IND for serious conditions
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An FDA submission required before a new drug can be administered to humans in clinical trials. Contains preclinical data, manufacturing information, and the clinical protocol.