emergency use INDA
- Guideline or reference source
- FDA www.fda.gov
- Definition
- Allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR ,Sec. 312.23 or Sec. 312.34. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
- Broader Term
- investigational new drug application
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