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Qdossier Qsauri
"F"

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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