Definition
IND (Investigational New Drug) is the FDA application that sponsors submit before initiating clinical trials in humans. The IND contains preclinical data demonstrating the drug is reasonably safe for initial testing and provides the clinical protocol for proposed studies.
How IND Works
Sponsors submit the IND to FDA’s Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER). FDA has 30 days to review; if no clinical hold is issued, trials may proceed.
Key Requirements
- Preclinical pharmacology and toxicology data
- Chemistry, manufacturing, and controls information
- Clinical protocol and investigator information
- Investigator brochure
- Institutional Review Board (IRB) approval documentation
Types of IND
| Type | Purpose | Use Case |
|---|---|---|
| Commercial IND | Drug development for marketing | Standard pharma/biotech |
| Investigator IND | Physician-sponsored research | Academic studies |
| Emergency Use IND | Life-threatening situations | Single patient access |
| Treatment IND | Expanded access | Serious conditions |
IND Lifecycle
- Pre-IND Meeting: Optional FDA consultation
- IND Submission: Day 0 of 30-day review
- FDA Review: Safety assessment
- Clinical Hold or Proceed: FDA decision
- Annual Reports: Ongoing submission requirements
- IND Amendments: Protocol changes, safety reports
Why BD Teams Track IND
For business development professionals, IND filings are key pipeline indicators:
- Deal Implication: IND-enabling studies and first-in-human trials represent inflection points for licensing discussions
- Due Diligence Focus: Evaluate preclinical package quality and FDA feedback from pre-IND meetings
- Opportunity Signal: Companies with multiple active INDs may seek partners for parallel development programs