Refuse-to-File Letter Issued

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.

Source: U.S. Food and Drug Administration Center for Drug Evaluation and Research Handbook.