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 products introduced to market shall be reviewed by the adjudicator to determine the viability of including the drug in the drug formulary.

  • New drug use and / or failure to attend and participate in the program will be interpreted as an indication of a more critical need for treatment.


More Definitions of New drug

New drug means either of the following:
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 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 (i) any drug the composition of which
New drug means: (i) any drug the composition of which is such that the drug is not
New drug means any drug considered to be a new drug under the federal act;
New drug means a drug: