Investigational or Experimental definition

Investigational or Experimental means a service, drug or device that meets one or more of the following criteria at the time it is provided, as determined by Us. The service, drug, or device: ▪ Cannot be legally marketed in the United States without the approval of the FDA and such approval has not been granted;▪ Is subject to a New Drug or New Device Application on file with the FDA;▪ Is provided as part of a Phase I or Phase II clinical trial, as the experimental or research arm of a Phase III clinical trial, or in any other manner that is intended to evaluate the safety, toxicity or efficacy of the service;▪ Is provided pursuant to a written protocol or other document that lists an evaluation of the safety, toxicity or efficacy of the service, drug or device among its objectives;▪ Is subject to the review or approval of an Institutional Review Board or other body that reviews or approves research concerning the safety, toxicity or efficacy of services, drugs or devices; or▪ Is provided pursuant to informed consent documents that describe the service, drug or device as Investigational or Experimental, or in other terms that indicate that the service, drug or device is being evaluated for its safety, toxicity or efficacy.
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Investigational or Experimental means a service, drug or device that meets one or more of the following criteria at the time it is provided, as determined by Us. The service, drug, or device:
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Examples of Investigational or Experimental in a sentence

  • Is one in which the improvement claimed is not demonstrated in the United States to be obtainable outside the Investigational or Experimental setting.

  • Denial of Experimental procedures or Investigational services is subject to Independent Medical Review (please refer to the "Independent Medical Review of Investigational or Experimental Therapies" portion of the "Specific Provisions" section for more information).

  • Investigational or Experimental: surgical or medical procedures, supplies, devices or drugs which, at the time provided or sought to be provided, are, in the judgment of the Corporation, not recognized as conforming to generally accepted medical or behavioral health practice in the United States, or the procedure, drug or device: 1.

  • INVESTIGATIONAL OR EXPERIMENTAL SERVICES‌ Services, supplies or drugs that are Investigational or Experimental.

  • It is an Investigational or Experimental service and it involves a life-threatening or seriously disabling condition.

  • If a service meets one or more of these criteria, it is Investigational or Experimental.

  • The Department does not require you to participate in Health Net’s grievance system or appeals process before requesting IMR of denials based on the Investigational or Experimental nature of the therapy.

  • There is insufficient information or inconclusive scientific evidence that the service is beneficial to the person's health and is as beneficial as any established alternatives when used in a noninvestigational setting.If a service meets one or more of these criteria, it is Investigational or Experimental.

  • Independent Medical Review of Investigational or Experimental TherapiesHealth Net does not cover Experimental or Investigational drugs, devices, procedures or therapies.

  • Is one in which the improvement claimed is not demonstrated to be obtainable outside the Investigational or Experimental setting.

Related to Investigational or Experimental

  • Experimental or Investigative means treatments, devices or prescription medications which are recommended by a Physician, but are not considered by the medical community as a whole to be safe and effective for the condition for which the treatments, devices or prescription medications are being used. This includes any treatments, procedures, facilities, equipment, drugs, drug usage, devices, or supplies not recognized as accepted medical practice, and any of those items requiring federal or other governmental agency approval not received at the time services are rendered.

  • Investigation means the Bureau’s decision to hold and not process the Company’s license renewal applications identified in Appendix A due to the Company’s inability to certify compliance with its public file obligations.

  • Background investigation means the investigation conducted by a licensee or applicant to support the determination of trustworthiness and reliability.

  • Experimental means a service, procedure, item or treatment that is “not proven and effective” for the conditions for which it is intended to be used.

  • Remedial investigation means a process to determine the nature and extent of a discharge of a contaminant at a site or a discharge of a contaminant that has migrated or is migrating from the site and the problems presented by a discharge, and may include data collected, site characterization, sampling, monitoring, and the gathering of any other sufficient and relevant information necessary to determine the necessity for remedial action and to support the evaluation of remedial actions if necessary;

  • Investigating Committee means any Officer/Committee appointed by Competent Authority to conduct investigation.

  • Study means the investigation to be conducted in accordance with the Protocol.

  • Investigation Committee means the Investigation Committee appointed by the Board under Regulation 5 of these Regulations;

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Evaluation means an appraisal of an individual’s professional performance in relation to his or her job description and professional standards and based on, when applicable, the individual’s evaluation rubric.

  • Victim or target of Nazi persecution means any individual persecuted or targeted for persecution by

  • Evaluation Team means the team appointed by the City; “Information Meeting” has the meaning set out in section 2.2;

  • Clinical means having a significant relationship, whether real or potential, direct or indirect, to the actual rendering or outcome of dental care, the practice of dentistry, or the quality of dental care being rendered to a patient;

  • Investigational Medicinal Product means the study drug or control material as defined in the Protocol.

  • Threatened species means endangered species, including flora and fauna, listed in the European Red List or the IUCN Red List, as referred to in Section 7 of Annex II to Delegated Regulation (EU) 2021/2139;

  • Threatened or endangered species means all spe- cies of wildlife listed as "threatened" or "endangered" by the United States Secretary of the Interior or Commerce, and all species of wildlife designated as "threatened" or "endan- gered" by the Washington fish and wildlife commission.

  • Studies means activities needed to prepare project implementation, such as preparatory, mapping, feasibility, evaluation, testing and validation studies, including in the form of software, and any other technical support measure, including prior action to define and develop a project and decide on its financing, such as reconnaissance of the sites concerned and preparation of the financial package;

  • Threatened litigation as used herein shall include governmental investigations and civil investigative demands. “Litigation” as used herein shall include administrative enforcement actions brought by governmental agencies. The Contractor must also disclose any material litigation threatened or pending involving Subcontractors, consultants, and/or lobbyists. For purposes of this section, “material” refers, but is not limited, to any action or pending action that a reasonable person knowledgeable in the applicable industry would consider relevant to the Work under the Contract or any development such a person would want to be aware of in order to stay fully apprised of the total mix of information relevant to the Work, together with any litigation threatened or pending that may result in a substantial change in the Contractor’s financial condition.

  • Acute toxicity means concurrent and delayed adverse effects that result from an acute exposure and occur within any short observation period, which begins when the exposure begins, may extend beyond the exposure period, and usually does not constitute a substantial portion of the life span of the organism.