accelerated development
- Guideline or reference source
- FDA www.fda.gov
- Definition
- After the IND has been filed, a drug that can be used by patients who are suffering from life-threatening or seriously debilitating conditions, for which no other drug treatment exists, can qualify for accelerated development. Approval can be based on surrogate endpoints or on an FDA determination that the drug can be used safely if distribution is limited
- Related Term
- investigational new drug application
- surrogate variable
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