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" new drug" means— (1) 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... "
United States Code - Page 1133
by United States - 1964
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Notices of Judgment Under the Federal Food, Drug, and ..., Issues 5501-7120

United States. Food and Drug Administration - 1959 - 1068 pages
...contentions each party has moved for summary judgment. The statute, 21 USC §321(p)(l) defines a new drug as 'any drug the composition of which is such that such...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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Miscellaneous Publication, Issue 1

United States. Food and Drug Administration - 1947 - 140 pages
...in clause (1), (2), and (3); but does not include devices or their components, parts, or accessories The term "new drug" means (1) any drug the composition...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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United States Code, Volume 6

United States - 1977 - 1276 pages
...man, including any drug intended for use in animal feed but not including such animal feed,— (1) the composition of which is such that such drug is...experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1990 - 782 pages
...than man, including any drug intended for use in animal feed but not including such animal feed: (1) The composition of which is such that such drug is...experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested...
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Chemicals in Food Products

United States. Congress. House. Select Committee to Investigate the Use of Chemicals in Food Products - 1951 - 896 pages
...paragraph (p) of the Food, Drug, and Cosmetic Act of June 25, 1938. It reads : The term "new drug" means any drug the composition of which is such that such...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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Residues of Pesticide Chemicals ...: Hearing ... on S. 2868 and H.R. 7125 ...

United States. Congress. Senate. Committee on Labor and Public Welfare - 1954 - 116 pages
...dressing, ointment, dusting powder, or such other use as involves prolonged contact with the body. (p) The term "new drug" means — (1) Any drug the...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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Federal Food, Drug, and Cosmetic Act (chemical Additives in Food).

United States. Congress. House. Committee on Interstate and Foreign Commerce - 1956 - 264 pages
...do now on 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...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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Federal Food, Drug, and Cosmetic Act (chemical Additives in Food): Hearing ...

United States. Congress. House. Committee on Interstate and Foreign Commerce - 1956 - 288 pages
...do now on 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...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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Drug Industry Antitrust Act, 87-1&2

United States. Congress. Senate. Judiciary - 1961 - 1226 pages
...from the present act. The bill simply adds "and efficacy" or "efficacious" wherever "safety" appears. Any drug the composition of which Is such that such...among experts qualified by scientific training and experience to evaluate the safety of the drug as safe to use under the conditions prescribed, recommended...
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Drug Industry Act of 1962: Hearings ... Eighty-seventh Congress, Second ...

United States. Congress. House. Committee on Interstate and Foreign Commerce - 1962 - 734 pages
...for convenience) CHAPTER II—-DEFINITIONS SEC. 201. For the purposes of this Act— * * * * * . * * (p) The term "new drug" means— (1) Any drug the...training and experience to evaluate the safety and efficacy of drugs, as safe and efficacious for use under the conditions prescribed, recommended, or...
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