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 any article drug that has an investigational drug application (INDA) that has been approved by the FDA.
Examples of Investigational drug in a sentence
The cost of a non-FDA approved Investigational drug, device or procedure is not Covered.
The Investigational drug, biological product, device, medical treatment or procedure itself.
Investigational drug solution should be prepared and transferred using aseptic technique in a biological safety cabinet.
Investigational drug must be kept in an appropriate, limited-access, secure place until it is used or returned to the sponsor or designee for destruction.
Investigational drug supplies should not be repackaged in any way.
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 a drug that:
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.