new drug
Defined in 2 dictionaries — Case Law, U.S. Code
Definitions from Case Law
From 412 U.S. 609 - Weinberger v. Hynson, Westcott & Dunning, Inc. · 1973Most cited · 1,273 citing opinions
—its power to approve or withdraw approval of NDA's.
United States Code
21 U.S.C. § 321 — for the purposes of this chapter
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 conditions 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 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.
42 U.S.C. § 300CC — for purposes of this section (6 versions over time)
For purposes of this section, the term “new drug” has the meaning given such term in section 321 of title 21.