FDA approvable letter
- Guideline or reference source
- CDISC Glossary of terms
- Definition
- An official communication from FDA to an NDA/ BLA sponsor that lists issues to be resolved before an approval can be issued. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)]
- Used For
- approvable letter
- Related Term
- approval document
- FDA action letter
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