Unit
- Investigational New Drug Application: An IND is a formal request submitted to the FDA for authorization to administer an experimental drug to humans in clinical trials. It is not an approval but a permission to initiate testing under specific regulatory conditions.
- Regulatory Basis: The IND process is codified in Title 21 of the Code of Federal Regulations (21 CFR Part 312), which establishes the requirements for drug sponsors, including data submission, safety monitoring, and recordkeeping.
- Historical Context: The requirement for IND submission emerged after thalidomide-induced birth defects in the 1960s, leading to the 1962 Kefauver-Harris Amendments that mandated proof of safety and efficacy before clinical testing.
- Primary Goals: INDs protect human subjects from unreasonable risks, ensure data integrity for subsequent marketing applications, and provide a framework for FDA oversight throughout clinical development.
- Sponsor Responsibility: The party taking responsibility for the investigation, typically a pharmaceutical company, academic institution, or individual investigator, must submit the IND and comply with all regulatory obligations.
- FDA Role: The FDA reviews the IND within 30 days of receipt; if no clinical hold is issued, the sponsor may begin trials. The agency may also provide guidance and impose holds for safety concerns.
- Types of INDs: Commercial INDs are filed by companies seeking eventual marketing approval, while research (non-commercial) INDs are submitted by academic or government researchers for investigator-initiated studies.
- Lifecycle Relevance: The IND remains active until all clinical studies are completed or terminated, and it serves as the foundation for the eventual New Drug Application (NDA) or Biologics License Application (BLA).
- IND Components: A complete IND submission must include the clinical protocol detailing study design and participant selection criteria, chemistry manufacturing and controls (CMC) data ensuring product quality, and pharmacology toxicology reports from preclinical animal studies. Investigator brochures and informed consent documents are also required to ensure ethical oversight and participant safety throughout the trial.
- Ongoing Obligations: After IND activation, sponsors have ongoing responsibilities including annual reporting to the FDA summarizing study progress, safety data, and any amendments. They must also promptly submit serious and unexpected adverse event reports. These obligations ensure continuous regulatory oversight and protect human subjects throughout the clinical investigation.
Scope of Practice
Role: Regulatory Affairs Associate in Pharmaceutical Development
Within scope:
- Preparing and compiling IND application components including preclinical reports, CMC data, and clinical protocols.
- Coordinating with cross-functional teams to ensure data completeness and regulatory compliance.
- Submitting the IND via the FDA Electronic Submission Gateway and tracking 30-day review period.
- Responding to FDA information requests and clinical hold communication.
Outside scope:
- Making scientific or medical decisions regarding study design or sample size.
- Interpreting clinical trial data for safety signals without medical supervision.
- Authorizing or approving changes to the clinical protocol independently.
- Representing the sponsor in direct FDA meetings without higher-level regulatory management.
Regulatory Note
Regulation: 21 CFR 312.20 specifies that a sponsor must submit an IND to the FDA before initiating any clinical investigation involving a drug subject to the Federal Food, Drug, and Cosmetic Act. The IND must include the clinical protocol, investigator information, and data from preclinical studies.
Source: 21 CFR 312.20 - Investigational New Drug Application
Quick Revision
- An IND is a regulatory application to obtain FDA permission to test an investigational drug in humans.
- It is governed by 21 CFR Part 312 and was established after the thalidomide tragedy to protect human subjects.
- Sponsors are responsible for submission and compliance; FDA reviews within 30 days.
- INDs can be commercial or research types, and they form the basis for later marketing applications.