Investigational drug definition

Investigational drug means any drug which has not been approved for use in the United States, but for which an investigational drug application has been approved by the Food and Drug Administration (FDA).

Investigational drug means any medication with an approved investigation new drug application on file with the federal Food and Drug Administration (FDA), that is being scientifically tested and clinically evaluated to determine its efficacy, safety and side effects and that has not yet received FDA approval;

Investigational drug means a drug that:

Examples of Investigational drug in a sentence

• Investigational drug means any medication with an approved investigational new drug (IND) application on file with the Food and Drug Administration (FDA), which is being scientifically tested and clinically evaluated to determine its efficacy, safety and side effects and which has not yet received FDA approval.

• The cost of a non-FDA approved Investigational drug, device or procedure is not Covered.

• Patient Cost does not include the cost of an Investigational drug or device, the cost of non-health care services that a Member may be required to receive as a result of the treatment being provided for purposes of the clinical trial, costs associated with managing the research associated with the clinical trial, or costs that would not be covered under this Evidence of Coverage for non- Investigational treatments.

• Investigational drug orders are restricted according to policy (see “Investigational/Experimental Drugs” policy).

• Routine costs do not include any of the following:  The Investigational drug, biological product, device, medical treatment or procedure itself.

More Definitions of Investigational drug

Investigational drug means any medication with an approved investigational new drug (IND) application on file with the Food and Drug Administration (FDA), which is being scientifically tested and clinically evaluated to determine its efficacy, safety, and side effects and which has not yet received FDA approval.

Investigational drug means any article drug that has an investigational drug application (INDA) that has been approved by the FDA.

Investigational drug means any article which has not been approved for use in the United States, but for which an investigational drug application (IND) has been approved by the FDA.

Investigational drug means any article that has an inves- tigational drug application (INDA) has been approved by the FDA.

Investigational drug means a drug that has not been approved for use in the United States, but for which an investigational drug application has been approved by the FDA.

Investigational drug means a drug that is being investigated for human or animal use by the manufacturer or the Food and Drug Administration (FDA); a drug which has not been approved for use by the FDA;

Investigational drug means a drug under study by the United States food and drug administration to determine safety and efficacy in humans for a particular indication.