Investigational definition

Investigational means the study drug being tested is not approved by the United States Food and Drug Administration (FDA).

Investigational means the definition provided in the covered person's health benefit plan; if the health benefit plan does not provide a definition of "investigational," it shall be defined as follows: Any treatment, procedure, facility, equipment, drug, device or commodity, regardless of its medical necessity, which is experimental, or in the early developmental stage of medical technology, for which there are no randomized clinical trials or, absent such trials, for which there are no cohort studies or case-control studies or, absent such studies, then for which there is no case-series. The determination by the health carrier will be based on objective data and information obtained by the health carrier and reviewed, by competent medical personnel, according to the following:

Investigational means that the drug has not been approved by the United States (US) Food and Drug Administration (FDA). Study drug and placebo will be given as a liquid which you will drink, or a tablet(s) which you will swallow whole. The placebo looks like the study drug but does not contain any active ingredients. Researchers will compare the results of taking the placebo to the results of taking the study drug to see if there are any differences. Midazolam will also be given in this study (Part C only, if done). Midazolam is an approved marketed drug. It is used as a sedative usually given before surgery or a procedure. It has a calming or sleep inducing effect. It may also be used to treat seizures and anxiety. However, the use of midazolam in this research study is investigational. Midazolam will be given as a liquid which you will drink. ABOUT THE STUDY

Examples of Investigational in a sentence

• Procedures that are considered to be Experimental or Investigational or Unproven Services.

• The fact that an Experimental or Investigational or Unproven Service, treatment, device or pharmacological regimen is the only available treatment for a particular condition will not result in Benefits if the procedure is considered to be Experimental or Investigational or Unproven in the treatment of that particular condition.

• The fact that an Experimental, or Investigational or Unproven Service, treatment, device or pharmacological regimen is the only available treatment for a particular condition will not result in benefits if the procedure is considered to be Experimental or Investigational or Unproven Service in the treatment of that particular condition.

• Routine colorectal cancer screening shall not mean services otherwise excluded from Benefits because the services are deemed by Us to be Investigational.

• Experimental or Investigational Services and Unproven Services and all services related to Experimental or Investigational and Unproven Services are excluded.

More Definitions of Investigational

Investigational means that the procedure, treatment, supply, device, equipment, facility or drug (all services) does not meet the Company’s Technology Evaluation Criteria because it does not meet one or more of the following criteria:

Investigational means that the drug has not been approved by the United States (US) Food and Drug Administration (FDA). Study drug and placebo will be given as a suspension (a liquid) which you will drink or as a tablet(s). The placebo looks like the study drug but does not contain any active ingredients. Researchers will compare the results of taking the placebo to the results of taking the study drug to see if there are any differences. Part B, Dosing Sequence 1, Period 1 A dietary fiber supplement may also be given in this part of the study to ensure regular bowel movements. Prune juice and a stool softener (docusate) or mild laxative (milk of magnesia) may also be given to ensure a daily bowel movement during fecal sample collection.

Investigational means that the drugs have not been approved by the United States (US) Food and Drug Administration (FDA).

Investigational means)) - A term to describe a pro- cedure, or course of treatment, which lacks sufficient scien- tific evidence of benefit for a particular condition. A service is not "investigational" if the service:

Investigational means that the drug has not been approved by the United States (U.S.) Food and Drug Administration (FDA). Study drug will be given as tablets, which you will swallow. ABOUT THE STUDY

Investigational means that IPX203 is being tested and has not been approved for marketing in the United Kingdom by the Medicines & Healthcare products Regulatory Agency (MHRA). IPX203 is being investigated to determine whether the drug is safe and has a better effect than the currently marketed forms of IR CD-LD (e.g. Sinemet). If successful, the drug could possibly improve the daily control of motor symptoms in people with Parkinson’s disease.

Investigational means a term to describe a procedure, or course of treatment, which lacks sufficient scientific evi- dence of benefit for a particular condition. A service is not "investigational" if the service: