 | United States. Patent Office - 1964 - 972 pages
...of which are required to be submitted to the Secretary pursuant to subsection (b) of this section, do not Include adequate tests by all methods reasonably...recommended, or suggested In the proposed labeling thereof; (2) the results of such tests show that such drug Is unsafe for use under such conditions or do not... | |
 | 1939 - 1496 pages
...investigations, reports of which are required to be submitted to the Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably...recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not... | |
 | United States. Food and Drug Administration - 1959 - 1068 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 labelling thereof, * * •.' Having determined that the seized articles are a drug, we look to the... | |
 | United States - 1977 - 1276 pages
...of which are required to be submitted to the Secretary pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably...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 or do not... | |
 | United States - 1964 - 1098 pages
...of which are required to be submitted to the Secretary pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably...recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions or do not... | |
 | United States. Food and Drug Administration - 1947 - 140 pages
...provision of the act which classes as a "new drug" any drug not generally recognized among experts as safe for use under the conditions prescribed, recommended, or suggested in the labeling. The cosmetic manufacturer did not know that any coal-tar dye used in his products must not... | |
 | 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 said application... | |
 | 1969 - 668 pages
...that: (1) The investigations, reports of which are required to be submitted pursuant to section 505 (b) of the act, do not include adequate tests by all methods...proposed labeling thereof ; or (2) The results of such testa show that such drug is unsafe for use under such conditions or do not show that such drug is... | |
 | 1981 - 1252 pages
...that: (1) The investigations, reports of which are required to be submitted pursuant to section 505(b) of the act, do not include adequate tests by all methods...suggested in the proposed labeling thereof; or (2) The result of such tests show that such drug is unsafe for use under such conditions or do not show that... | |
 | 1961 - 674 pages
...that: (a) The investigations, reports of which are required to be submitted pursuant to section 505 (b) of the act, do not include adequate tests by all methods...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 or do not... | |
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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... 
