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" Secretary pursuant to subsection (b), do 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... "
Notices of Judgment Summarizing Judicial Review of Orders Under Section 701 ... - Page 69
by United States. Food and Drug Administration - 1944
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Animal Drug Amendments of 1967, Hearing Before the Subcommittee on Public ...

United States. Congress. House. Interstate and Foreign Commerce - 1967 - 66 pages
...apply, he shall issue an order approving the application. "(2) In determining whether such drug is safe for use under the conditions Prescribed, recommended, or suggested in the proposed labeling thereof, the ecretary shall consider, among other relevant factors, (A) the probable consumption of...
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Committee Prints

United States. Congress. Senate. Committee on Labor and Public Welfare - 1969
...not apply, he shall issue an order approving the application. (2) In determining whether such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Secretary shall consider, among other relevant factors, (A) the probable consumption of...
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Hearings, Reports and Prints of the Senate Committee on Labor and Public Welfare

United States. Congress. Senate. Committee on Labor and Public Welfare - 1969
...not apply, he shall issue an order approving the application. (2) In determining whether such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the Secretary shall consider, among other relevant factors, (A) the probable consumption of...
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Federal Food, Drug, and Cosmetic Act with Amendments

United States - 1970 - 125 pages
...recognized, among experts qualified by scientific training and experience to evaluate the safety of drugs, as safe 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";...
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Laws Relating to Agriculture

United States - 1971
...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 tor use under such conditions...
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FDA Consumer, Volume 10

1976
...reports of the investigations submitted do not include adequate tests showing whether the new drug is 'safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof.' . . . Defendants argue that the term 'safe' should be interpreted with reference not only...
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Agriculture--environmental and Consumer Protection Appropriations ..., Part 4

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture--Environmental and Consumer Protection Appropriations - 1972
...time. Prior to 1962, sponsors of new drugs were required to prove only that their products would be safe for use under the conditions prescribed, recommended or suggested in the labeling. In making judgements as to safety, the Food and Drug Administration could and did insist...
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Compilation of Selected Public Health Laws, Prepared for the Use of the ...

United States. Congress. House Interstate and Foreign Commerce - 1973 - 162 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 ; (B) the results of such tests show that such drug is unsafe for use under such conditions...
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Use of Advisory Committees by the Food and Drug Administration: Hearings ...

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations Subcommittee - 1974
...reports include adequate tests by all methods reasonably accurate to show whether or not the drug is safe for use under the conditions prescribed, recommended or suggested in the proposed labeling for it. 2. That the results of such tests show that the drug is safe for use. 3. That FDA has sufficient...
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Agriculture--environmental and Consumer Protection Appropriations for 1975 ...

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture--Environmental and Consumer Protection Appropriations - 1974
...nut 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; (B) the results of such tests show that such drug is unsafe for use under such conditions...
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