New Drug Application (NDA)
A formal submission to the US FDA containing all preclinical, clinical, manufacturing, and labelling data needed to demonstrate a new drug is safe and effective. NDA approval allows marketing in the United States. Standard review takes 10-12 months; priority review takes 6-8 months.
Technical Context
NDA structure follows the Common Technical Document (CTD) format: Module 1 (administrative/regional), Module 2 (quality/nonclinical/clinical overviews and summaries), Module 3 (quality — CMC: chemistry, manufacturing, controls), Module 4 (nonclinical study reports), Module 5 (clinical study reports). Review involves multidisciplinary teams: medical officers, biostatisticians, pharmacologists, chemists, and others. Standard NDA review: 10-month PDUFA goal date (12 months from filing). Priority review: 6-month PDUFA goal date (8 months from filing). User fees: PDUFA VII (2023-2027) application fee approximately $4 million. FDA actions at PDUFA date: approval, complete response letter (CRL, identifying deficiencies), or (rarely) refusal to file. Most peptide drugs use the NDA pathway; larger peptide-proteins may use the BLA pathway.