Regulatory Reference
IND Application Guide
Investigational New Drug (IND) requirements for initiating clinical trials in the United States — filing contents, 30-day FDA review, clinical hold, and ongoing obligations.
What is an IND?
An IND authorizes a sponsor to ship an investigational drug across state lines and conduct clinical studies in humans. Without an active IND (or exempt expanded access pathway), interstate distribution for clinical investigation is prohibited under 21 CFR 312.
The IND must convince FDA that the proposed trial does not expose subjects to unreasonable risk and that the investigational product is adequately characterized for the planned dose and duration.
IND types
| Type | Sponsor | Typical use |
|---|---|---|
| Commercial IND | Pharma / biotech sponsor | Development toward NDA/BLA approval |
| Research IND | Investigator-sponsor (academic) | Non-commercial clinical research |
| Treatment IND / protocol | Sponsor | Seriously ill patients outside trials (when criteria met) |
| Emergency IND | Physician + FDA contact | Single-patient emergency before formal IND |
Core filing contents
- Form FDA 1571 — application cover sheet and administrative information
- Form FDA 1572 — statement of investigator for each clinical site
- Chemistry, Manufacturing, and Controls (CMC) — drug substance/product characterization, stability, container closure
- Pharmacology & toxicology — animal data supporting Phase I dose and exposure duration
- Clinical protocols — detailed study design, inclusion/exclusion, endpoints, safety monitoring
- Investigator's brochure (IB) — summary of nonclinical and clinical data for investigators
30-day review & clinical hold
FDA has 30 days from IND receipt to review. If the agency does not issue a clinical hold within that window, the sponsor may proceed with the proposed studies (subject to IRB approval and other local requirements).
A clinical hold delays or stops the trial when FDA finds inadequate information to assess risk, or when subjects would be exposed to unreasonable and significant risk. The sponsor must resolve deficiencies before studies resume.
Ongoing IND obligations
- Annual report — due within 60 days of each IND anniversary (development summary, safety update)
- IND safety reports — expedited reporting for serious and unexpected suspected adverse reactions
- Protocol amendments — submit substantial changes before implementation when required
- Information amendments — new pharmacology/toxicology, CMC, or clinical data as generated