Common use of Food and Drug Administration Clause in Contracts

Food and Drug Administration. The study or investigation is a drug trial that is exempt from having such an investigational new drug application. • The clinical trial must have a written protocol that describes a scientifically sound study. It must have been approved by all relevant institutional review boards (IRBs) before you are enrolled in the trial. We may, at any time, request documentation about the trial. • The subject or purpose of the trial must be the evaluation of an item or service that meets the definition of a Covered Health Care Service and is not otherwise excluded under this Policy.

Appears in 14 contracts

Samples: Individual Exchange Medical Policy, Individual Exchange Medical Policy, Individual Exchange Medical Policy

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Food and Drug Administration. The study or investigation is a drug trial that is exempt from having such an investigational new drug application. The clinical trial must have a written protocol that describes a scientifically sound study. It must have been approved by all relevant institutional review boards (IRBs) before you are enrolled in the trial. We may, at any time, request documentation about the trial. The subject or purpose of the trial must be the evaluation of an item or service that meets the definition of a Covered Health Care Service and is not otherwise excluded under this Policy.

Appears in 1 contract

Samples: Individual Medical Policy

Food and Drug Administration. The study or investigation is a drug trial that is exempt from having such an investigational new drug application. • The clinical trial must have a written protocol that describes a scientifically sound study. It must study and have been approved by all relevant institutional review boards (IRBs) before you participants are enrolled in the trial. We may, at any time, request documentation about the trial. • The subject or purpose of the trial must be the evaluation of an item or service that meets the definition of a Covered Health Care Service and is not otherwise excluded under this the Policy.

Appears in 1 contract

Samples: Group Policy

Food and Drug Administration. The study or investigation is a drug trial that is exempt from having such an investigational new drug application. SAMPLE • The clinical trial must have a written protocol that describes a scientifically sound study. It must have been approved by all relevant institutional review boards (IRBs) before you are enrolled in the trial. We may, at any time, request documentation about the trial. • The subject or purpose of the trial must be the evaluation of an item or service that meets the definition of a Covered Health Care Service and is not otherwise excluded under this Policy.

Appears in 1 contract

Samples: Individual Exchange Medical Policy

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Food and Drug Administration. SAMPLE • The study or investigation is a drug trial that is exempt from having such an investigational new drug application. • The clinical trial must have a written protocol that describes a scientifically sound study. It must have been approved by all relevant institutional review boards (IRBs) before you are enrolled in the trial. We may, at any time, request documentation about the trial. • The subject or purpose of the trial must be the evaluation of an item or service that meets the definition of a Covered Health Care Service and is not otherwise excluded under this Policy.

Appears in 1 contract

Samples: Individual Exchange Medical Policy

Food and Drug Administration. The study or investigation is a drug trial that is exempt from having such an investigational new drug application. • The clinical trial must have a written protocol that describes a scientifically sound study. It must have been approved by all relevant institutional review boards (IRBs) before you are enrolled in the trial. We may, at any time, request documentation about the trial. SAMPLE • The subject or purpose of the trial must be the evaluation of an item or service that meets the definition of a Covered Health Care Service and is not otherwise excluded under this Policy.

Appears in 1 contract

Samples: Individual Exchange Medical Policy

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