Investigational New Drug Application (IND)
An FDA application that authorizes a pharmaceutical company to begin clinical trials of an unapproved drug or biological product in humans.
Before a sponsor can ship an investigational drug across state lines for clinical testing, they must submit an IND to the FDA under 21 CFR Part 312. The IND must include: preclinical data demonstrating sufficient safety to justify human trials; the proposed clinical protocol; investigator information and qualifications; and chemistry, manufacturing, and controls (CMC) data describing the drug substance and product.
The FDA has 30 days to review the initial IND and may place a clinical hold if safety concerns warrant it. Once in effect, the IND must be updated annually (Annual Report) and amended for protocol changes, new investigators, and safety updates. Managing an IND file over a multi-year development program generates thousands of documents across dozens of amendments. Document intelligence enables regulatory affairs teams to search across the entire IND history — finding specific protocol versions, safety updates, and CMC amendments — in seconds rather than hours.
Related Terms
More compliance Terms
General Data Protection Regulation (GDPR)
The European Union regulation governing how organizations collect, process, store, and protect personal data.
SOC 2
An auditing framework that evaluates an organization's controls for security, availability, processing integrity, confidentiality, and privacy.
HIPAA
The U.S. federal law that establishes standards for protecting sensitive patient health information.
Audit Trail
A chronological record of system activities that provides documentary evidence of the sequence of actions performed.
Data Privacy
The practice of handling personal information in accordance with legal requirements and individual expectations about data use.
PCI DSS
The Payment Card Industry Data Security Standard — a set of requirements for organizations that handle credit card information.
Analyze Documents Related to Investigational New Drug Application (IND)
Upload any document and get AI-powered analysis with verifiable citations.
Start Free