 | United States. Congress. Senate. Committee on Labor and Public Welfare - 1969 - 1202 pages
...— (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...experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in... | |
 | United States. Congress. Senate. Committee on Labor and Public Welfare - 1969 - 1282 pages
...— (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...experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in... | |
 | Michael R. Sonnenreich, Robert L. Bogomolny, Robert J. Graham - 1969 - 116 pages
...National Formulary, or any supplement to any of them. F. The term "new drug" means — 1 . Any drug the composition of which is such that such drug is...experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in... | |
 | United States - 1970 - 140 pages
...investigations, been used to a material extent or for a material time under such conditions. (1) Any drug the composition of which is such that such drug is...among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended,... | |
 | United States - 1936 - 1258 pages
...other use as involves prolonged contact with the body. (p) The term "new drug means — (1) Any drug he purpose by the Secretary. Any person required by...regulations promulgated thereunder, to furnish reports or experience to evaluate the safety of drugs, as safe for use under the conditions prescribed, recommended,... | |
 | 1980 - 468 pages
...the issue of whether X-Otag Plus is a 'new drug.' "The FDCA defines a 'new drug' to be: "Any drug ... the composition of which is such that such drug is...experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in... | |
 | United States. Congress. House. Interstate and Foreign Commerce - 1972 - 334 pages
...drug or an animal feed bearing or containing a new animal drug) the composition of which is such thnt such drug is not generally recognized, among experts...experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suegested in... | |
 | United States. Congress. Senate. Labor and Public Welfare - 1972 - 100 pages
...animal feed bearing or containing a new animal drug) the composition of which is such that such drug, as not generally recognized, among experts qualified...experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in... | |
 | United States. Congress. Senate. Select Committee on Small Business - 1972 - 638 pages
...Food, Drug, and Cosmetic Act. All hydrophilic soft contact lenses are thus "new drugs" because they are not generally recognized, among experts qualified...experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under conditions prescribed, recommended, or suggested in the... | |
 | 1977 - 408 pages
...the definition set out in § 32l(p) of the Act. That section provides that a 'new drug' is any drug 'not generally recognized, among experts qualified...experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in... | |
| |
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... 
