Investigational New Drug (IND) Application

An Investigational New Drug (IND) Application is a limited clinical investigation program that has been approved by the U.S. Food and Drug Administration to start human clinical trials for the purpose of researching and testing a new pharmaceutical drug.

• AKA: Investigational New Drug (IND) Program.
• Context:
  • It can (typically) be required before starting a Drug Development Clinical Trial.
  • It can range from being an Investigator-Initiated Investigational New Drug (IND) Application, to being a Treatment Investigational New Drug (IND) Application to being an Emergency Investigational New Drug (EIND) Application.
  • It can range from being a Commercial Investigational New Drug (IND) Application, to being a Screening Investigational New Drug (IND) Application, to being a Research Investigational New Drug (IND) Application.
  • It can be categorized by the following subcategories:
    • Preclinical Testing IND Program,
    • Manufacturing Information IND Program,
    • Investigator Information IND Program,
    • Clinical Trial Protocol IND Program.
• Example(s):
  • …
• Counter-Example(s):
  • Early Feasibility Studies (EFS) Program,
  • Investigational Device Exemption (IDE) Program,
  • Medical Device Development Clinical Trial.
• See: Pre-Investigational New Drug Application (IND) Consultation Program, Preclinical Trial, Microdosing Clinical Trial, Approved Drug, Pharmaceutical Industry.

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References

2022a

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Investigational_New_Drug Retrieved:2022-1-22.
  • The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. Regulations are primarily at 21 CFR 312. Similar procedures are followed in the European Union, Japan, and Canada.

2022b

• (FDA, 2022) ⇒ https://www.fda.gov/drugs/types-applications/investigational-new-drug-ind-application Retrieved:2022-1-22.
  • QUOTE: Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA.

    During a new drug's early preclinical development, the sponsor's primary goal is to determine if the product is reasonably safe for initial use in humans, and if the compound exhibits pharmacological activity that justifies commercial development. When a product is identified as a viable candidate for further development, the sponsor then focuses on collecting the data and information necessary to establish that the product will not expose humans to unreasonable risks when used in limited, early-stage clinical studies.

    FDA's role in the development of a new drug begins when the drug's sponsor (usually the manufacturer or potential marketer), having screened the new molecule for pharmacological activity and acute toxicity potential in animals, wants to test its diagnostic or therapeutic potential in humans. At that point, the molecule changes in legal status under the Federal Food, Drug, and Cosmetic Act and becomes a new drug subject to specific requirements of the drug regulatory system.

    There are three IND types:

    • An Investigator IND is submitted by a physician who both initiates and conducts an investigation (...)
    • Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation (...)
    • Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions (...)

There are two IND categories:

• Commercial
• Research (non-commercial).

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