Definitions for "Investigational New Drug"
Related Terms:
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An application submitted to the FDA for approval before any clinical trials involving the use of the investigational drug in humans can commence.
A drug permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.
The status of an experimental drug after the Food and Drug Administration agrees that it can be tested in people.
A novel chemical substance used to affect the function of the mind or body with the intention of diagnosing, preventing, or treating a disease, a condition, or its symptoms. An IND is not yet FDA approved for marketing to treat a particular condition, but it must be investigated in clinical trials to gather data that FDA will consider for the marketing approval application.
An authorization given by the Food and Drug Administration (FDA) to administer a new drug, antibiotic drug, or biological drug to humans in a clinical trial. It also includes a biological product used in vitro for diagnostic purposes.
Investigational New Drug (IND). An investigational drug is one that is under study but does not yet have permission from the U.S. Food and Drug Administration (FDA) to be legally marketed and sold in the United States. FDA approval is the final step in the process of drug development. The first step in the process is for the new drug to be tested in the laboratory. If the results are promising, the drug company or sponsor must apply for FDA approval to test the drug in people. This is called an Investigational New Drug (IND) Application. Once the IND is approved, clinical trials can begin.
A drug that the Food and Drug Administration (FDA) allows.
a drug or biological product that is unapproved by the FDA.
An Investigational New Drug (IND) Application is a request for authorization from the FDA to administer an investigational drug or biological product to humans.
A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.
The name given to an experimental drug after the Drugs Directorate of Health and Welfare Canada has agreed that it can be tested in people.
Refers to the Food and Drug Administrationâ€(tm)s (FDA) program by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND for safety to assure that research subjects will not be subjected to unreasonable risk. The application has three main sub-sections: Animal Pharmacology and Toxicology Studies; Manufacturing Information; and Clinical Protocols and Investigator Information.
a drug classification used by the U.S. FDA to indicate an experimental drug can be tested in people. (commonly abbreviated IND or INDA)
an FDA classification applied to experimental drugs undergoing trials to assess safety and efficacy prior to marketing approval. IND status must be granted before a drug can enter Phase I testing. See also treatment IND, supplemental IND.
a drug that the FDA allows to be used in human clinical trials in order to gain information for evaluation by the FDA, usually for approval of commercial marketing.
A drug allowed by the Food and Drug Administration (FDA) to be used in clinical trials but not approved by the FDA for commercial marketing.
an application to pursue clinical trials with an experimental drug that has passed pre-clinical trials.
Drugs approved by the U.S.Food and Drug Administration for clinical testing in human subjects and patients.
Status given to an experimental drug after the Health Protection Branch ( HPB) approves an application for testing in volunteers.
a drug allowed by the US Food and Drug Administration (FDA) to be used in clinical trials, but not approved for sale to the general public.
The Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved. The FDA reviews the IND for safety to assure that research subjects will not be subjected to unreasonable risk.