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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 of... "
Notices of Judgment Under the Federal Food, Drug, and Cosmetic Act ... - Page 208
by United States. Food and Drug Administration - 1959
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Decisions of the Commissioner of Patents and of the United States Courts in ...

United States. Patent Office - 1964 - 972 pages
...not Include adequate tests by all methods reasonably applicable to show whether or not such drug Is safe for use under the conditions prescribed, recommended, or suggested In the proposed labeling thereof; (2) the results of such tests show that such drug Is unsafe for use under...
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Department of Agriculture Appropriations: Hearings Before the ..., Parts 1-2

United States. Congress. House. Committee on Appropriations - 1970 - 1054 pages
...agricultural commodities of poisonous or deleterious pesticide chemicals »nd of pesticide chemicals which are not generally recognized, among experts qualified...training and experience to evaluate the safety of pesticide chemicals, as safe for use, to the extent necessary to protect the public lw»lth. In establishing...
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United States Congressional Serial Set, Issue 10293

1939 - 1496 pages
...not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under...
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Miscellaneous Publication, Issue 1

United States. Food and Drug Administration - 1947 - 140 pages
...parts, or accessories The term "new drug" means (1) any drug the composition of which is such that such drug is not generally recognized, among experts...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"...
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United States Code, Volume 2

United States - 1964 - 1098 pages
...the Canal Zone. (p) The term "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 under the...
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United States Code, Volume 6

United States - 1977 - 1276 pages
...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...
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Notices of Judgment Summarizing Judicial Review of Orders Under ..., Issues 1-17

United States. Food and Drug Administration - 1944 - 154 pages
...pnrt of the application he had insufficient information to determine whether the drug "Diamonex" was safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling of said product ; and that respondent might issue an order refusing to permit the...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1965 - 1520 pages
...scientifically tested and shown to be safe. (b) Section 121.101 contains a partial list of substances that are generally recognized among experts qualified by scientific...training and experience to evaluate the safety of such substances as ingredients in food as safe for such use under the conditions set forth in that...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1967 - 566 pages
...scientifically tested and shown to be safe. (b) Section 121.101 contains a partial list of substances that are generally recognized among experts qualified by scientific...training and experience to evaluate the safety of such substances as ingredients in food as safe for such use under the conditions set forth in that...
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The Code of Federal Regulations of the United States of America

1963 - 1124 pages
...scientifically tested and shown to be safe. (b) Section 121.101 contains a partial list of substances that are generally recognized among experts qualified by scientific...training and experience to evaluate the safety of such substances as ingredients in food as safe for such use under the conditions set forth in that...
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