A New Drug Application NDA is a comprehensive submission to the FDA requesting approval to market a new pharmaceutical for sale in the U.S.
The NDA must provide sufficient evidence of the drug's safety, efficacy, and quality.
Key Sections of an NDA
Administrative Information
Forms and Cover Letters: Including Form FDA 356h.
Summary Documents
Overall Summary: High-level overview.
Clinical Overview: Summary of clinical data.
Non-Clinical Overview: Summary of non-clinical data.
Quality (CMC) Module
Detailed information on drug substance and product manufacturing.
Non-Clinical Study Reports
Pharmacology and Toxicology Studies: Full reports.
Clinical Study Reports
Efficacy Studies: Phase II and III trials.
Safety Data: Adverse events, laboratory findings.
Statistical Data
Statistical Analysis Plans: Methodologies used.
Data Listings and Tabulations
Labeling
Proposed package insert, prescribing information.
Patent Information
Details of patent exclusivity.
Other Information
Environmental Assessment
Risk Management Plans
DA Review Process of New Drug Application
Filing Review: FDA determines if the NDA is complete.
Review Team Assignment: Multidisciplinary team evaluates the NDA.
Review Clock: Standard review (10 months) or priority review (6 months).
Advisory Committee Meetings: External experts may be consulted.
FDA Decision: Approval, Complete Response Letter (requiring additional information), or denial.