| United States. Food and Drug Administration - 1959 - 1068 pages
...party has moved for summary judgment. The statute, 21 USC ยง321(p)(l) defines a new drug as '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 - 1977 - 1276 pages
...meansCD 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 - 1964 - 1098 pages
...the Commonwealth of Puerto Rico and the Canal Zone. (p) The term "new drug" means โ (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. Food and Drug Administration - 1947 - 140 pages
...not include devices or their components, parts, or accessories The term "new drug" means (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,... | |
| 1989 - 764 pages
...510.3 Definitions and interpretations. As used in this part: (a) The term "act" means the Federal Pood, Drug, and Cosmetic Act, as amended (sees. 201-902,...not generally recognized, among experts qualified by sciFood and Drug Administration, HHS entitle training and experience to evaluate the safety and effectiveness... | |
| 1986 - 792 pages
...means the Secretary of Health and Human Services. (d) "Commissioner" means the Commissioner of Pood and Drugs. (e) "Person" means individuals, partnerships,...among experts qualified by scientific training and experience to Food and Drug Administration, HHS evaluate the safety and effectiveness of animal drugs,... | |
| 1988 - 772 pages
...means the Secretary of Health and Human Services. (d) "Commissioner" means the Commissioner of Pood and Drugs. (e) "Person" means individuals, partnerships,...not generally recognized, among experts qualified by sci21 CFR Ch. I (4-1-88 Edition) entific training and experience to evaluate the safety and effectiveness... | |
| United States. Congress. Senate. Committee on Labor and Public Welfare - 1954 - 116 pages
...other use as involves prolonged contact with the body. (p) The term "new drug" means โ (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. Congress. House. Committee on Interstate and Foreign Commerce - 1956 - 288 pages
...foods, and the language that they used, Congressman, they said : The term "new drug" means 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,... | |
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