A drug is, among other things, an article (other than food) that:
Biological products may also be considered drugs within the meaning of the FD&C Act. It is important to note that the definition of drug is not limited to compounds intended for a therapeutic purpose. The definition also includes compounds intended to affect the structure or function of the body, without regard to whether the compound is intended to influence a disease process. For example, the definition includes compounds administered to healthy subjects to blunt or provoke a physiologic response or to study the mechanism of action or metabolism of a drug.
An Investigational New Drug (IND) application allows a sponsor to lawfully use an investigational drug for the purpose of conducting a clinical investigation of that drug.
An investigational drug can be an unapproved drug or an approved product being studied for a new indication or in a new patient population.
The FDA’s objectives are to assure data quality and study subject safety. In an initial IND submission, the sponsor provides:
Once approved, an IND grants the sponsor an exemption from the federal statute that prohibits shipping an unapproved drug in interstate commerce.
A clinical investigation is any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.
The sponsor of a clinical investigation that is not otherwise exempt from the IND requirements is responsible for submitting an IND application to FDA and obtaining Institutional Review Board (IRB) approval before the study can begin.
A clinical investigation of a drug is exempt from the IND requirements if all of the following criteria are met:
Historically, assessing whether a particular use of a drug in a clinical investigation significantly increases the risk, or decreases the acceptability of the risk, compared to its approved use, has been the most difficult issue in deciding whether an IND is needed for a clinical investigation of a marketed drug. If needed, specific guidance is available from the FDA.
A sponsor is a person who takes responsibility for and initiates a clinical investigation. A sponsor may be an individual, a pharmaceutical company, a government agency, an academic institution, or other organization. The sponsor submits and maintains the IND.
An investigator is an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject).
A sponsor-investigator is an individual who both initiates and conducts an investigation and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual.
Emergency Use and Treatment INDs are also known as “Compassionate Use” INDs, but the term “Compassionate Use” is not found in the IND regulations.
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