New drug definition

New drug means: (i) any drug, except a new animal drug or an animal feed bearing or containing

New drug means (i) any drug, except a new animal drug or an animal feed bearing or containing a new animal drug, the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling, except that such a drug not so recognized shall not be deemed to be a "new drug" if at any time prior to the enactment of this chapter it was subject to the Food and Drugs Act of June 30, 1906, as amended, and if at such time its labeling contained the same representations concerning the conditions of its use, or (ii) any drug, except a new animal drug or an animal feed bearing or containing a new animal drug, the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

New drug means either:

Examples of New drug in a sentence

• New drug entities for conditions without any available PDL choices in therapeutic classes not yet reviewed by the P&T Committee will remain payable, in effect preferred by default, until the therapeutic class is discussed.

• The change code and description: NEWA New drug product approval usually in the supplement month.CAHN Applicant holder firm name has changed.CAIN Change.

• New drug entities come to market every day, some in the form of FDA approvals of new products, reformulations of existing products, repackaged products, or drugs that are sold from one manufacturer to another.

• New drug treatments for the management of life-threatening fungal infections in immuno-suppressed patients such as those with HIV-AIDS or undergoing bone marrow transplantation are needed due to the constant development of drug resistance in these organisms.

• New drug therapies, which offer the prospect of significant improvements for patient outcomes, place increased budgetary pressures on hospitals and on general medical services in the community.

More Definitions of New drug

New drug means: (i) any drug the composition of which is such that such drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling thereof; or (ii) any drug the composition of which is such that such drug, as a result of investigations to determine its safety and effectiveness for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

New drug means either of the following:

New drug means a drug that is approved by the FDA after the date of this coverage. If these drugs fall into a covered class of drugs they will be subject to Prior Authorization for at least 90 days. If these drugs fall into an excluded class of drugs, they will be excluded from coverage.

New drug means a drug, the composition of which is such that:

New drug means (i) any drug the composition of which

New drug means any drug considered to be a new drug under the federal act;

New drug means any drug: