Definition
NDA (New Drug Application) is the comprehensive submission through which drug sponsors formally request FDA approval to market a new pharmaceutical product in the United States. The NDA contains all preclinical, clinical, manufacturing, and labeling data demonstrating the drug is safe and effective.
How NDA Works
After completing clinical trials under an IND, sponsors compile all evidence into the NDA submission. FDA reviews the complete package and issues either an Approval Letter or Complete Response Letter.
Key Requirements
- Preclinical pharmacology and toxicology data
- Human pharmacokinetics and bioavailability studies
- Clinical efficacy and safety data from Phase 1-3 trials
- Chemistry, manufacturing, and controls (CMC) information
- Proposed labeling and package insert
- Patent and exclusivity information
NDA Submission Types
| Type | Description | Use Case |
|---|---|---|
| 505(b)(1) | Full original NDA | New molecular entities |
| 505(b)(2) | References prior data | Modified drugs |
| Rolling | Submitted in sections | Expedited programs |
| Paper NDA | Literature-based | Well-characterized drugs |
NDA Review Timeline
The FDA follows PDUFA timelines for NDA review:
- Filing Review: 60 days to accept or refuse to file
- Standard Review: 10 months from filing
- Priority Review: 6 months from filing
- Advisory Committee: Optional expert panel meeting
- Decision: Approval Letter or Complete Response Letter
Recent NDA Statistics
In 2024, FDA’s Center for Drug Evaluation and Research (CDER) approved:
- 55 novel drugs (new molecular entities)
- 70% received at least one expedited designation
- Median review time: 10.5 months for standard, 6 months for priority
Why BD Teams Track NDA
For business development professionals, NDA submissions represent key milestones:
- Deal Implication: NDA filing often triggers milestone payments in licensing deals
- Due Diligence Focus: Review completeness of the NDA package and FDA interaction history
- Opportunity Signal: Companies approaching NDA submission often seek commercial partners