approval document
- Guideline or reference source
- CDISC Glossary of terms
- Definition
- An official communication from FDA to inform an applicant of a decision to allow commercial marketing consistent with conditions of approval. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)]
- Used For
- approval letter
- Narrower Term
- tentative approval letter for an ANDA
- Related Term
- FDA action letter
- FDA approvable letter
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