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"A"

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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