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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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Psychotropic Substances Act of 1973: Hearing Before the Subcommittee to ...

United States. Congress. Senate. Committee on the Judiciary - 1974 - 543 pages
...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." 21 USC g355(d) (1). See also 21 USC 355(d) (2) and (4). Defendants argue that the term...
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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 and Human Resources 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
...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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Agriculture-environmental and Consumer Protection Appropriations for Fiscal ...

United States. Congress. Senate. Appropriations Committee - 1974
...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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Code of Federal Regulations: Containing a Codification of Documents of ...

1976
...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; or (2) The result of such tests show that such drug Is unsafe for use under such conditions...
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Compilation of Selected Acts Within the Jurisdiction of the Committee on ...

United States - 1977
...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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Drug Regulation Reform Act of 1978: Hearings Before the Subcommittee on ...

United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Health and the Environment - 1978
...not include "adequate tests by all methods reasonably applicable to show whether or not [the] drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof;" C 2) the results of these tests show that the drug 1s "unsafe for use under such conditions...
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Food Safety and Quality: Hearings Before the Subcommittee on Agricultural ...

United States. Congress. Senate. Committee on Agriculture, Nutrition, and Forestry. Subcommittee on Agricultural Research and General Legislation - 1977
...data submitted by the applicant and otherwise available to FDA are adequate to show that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proi>osed labeling. 21 USC 300b(d) (1) (A), and (B) ; 21 USC 360b(d)(2). Once a new animal drug...
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Laetrile, the Commissioner's decision

United States. Food and Drug Administration - 1978 - 73 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 drag'...
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A Legislative History of the Federal Food, Drug, and Cosmetic Act ..., Volume 24

1979
...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 test* show that sicn drug is unsafe for jse under such conditions...
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