New Drug Law and Legal Definition
The term new drug means--
“(1) 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 condition prescribed, recommended, or suggested in the labeling thereof, 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 Act [enacted June 25, 1938] 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
(2) 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.”
Legal Definition list
Related Legal Terms
- Abbreviated Drug Application
- Abbreviated New Drug Applications [ANDA]
- Accidental Radiation Occurrence [Food and Drugs]
- Addictive Drug
- Adverse Drug Experience
- AIDS Drug Assistance Programs
- Animal Drug Availability Act
- Animal Drug Product [Food and Drugs]
- Animal Drug User Fee Act of 2003 [ADUFA]
- Anti-Drug Abuse Act
