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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