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Qsauri
"R"

refuse to file letter
Guideline or reference source
FDA www.fda.gov
Definition
New Drug Applications that are incomplete become the subject of a formal "refuse-to-file" action. In such cases, the applicant receives a letter detailing the decision and the deficiencies that form its basis. This decision must be forwarded within 60 calendar days after the NDA is initially received by CDER.
Used For
refuse to receive
Related Term
RTF
 

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