 | United States - Law - 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. Food and Drug Administration - Food law and legislation - 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... | |
 | Administrative law - 1992 - 744 pages
...that: (1) The reports of investigations required to be submitted pursuant to section 512(b) of the act do not include adequate tests by all methods reasonably...recommended, or suggested in the proposed labeling thereof; or (2) The results of such tests show that such drug is unsafe for use under such conditions or do... | |
 | Administrative law - 1995 - 616 pages
...that: (1) The reports of investigations required to be submitted pursuant to section 512(b) of the act do not include adequate tests by all methods reasonably...recommended, or suggested in the proposed labeling thereof; or (2) The results of such tests show that such drug is unsafe for use under such conditions or do... | |
 | Administrative law - 1974 - 402 pages
...that: (1) The reports of investigations required to be submitted pursuant to section 512 (b) of the act do not Include adequate tests by all methods reasonably...recommended, or suggested In the proposed labeling thereof ; or (2) The results of such tests show that such drug is unsafe for use under such conditions or do... | |
 | Administrative law - 1995 - 1360 pages
...that: (1) The reports of investigations required to be submitted pursuant to section 512(b) of the act do not include adequate tests by all methods reasonably...applicable to show whether or not such drug is safe for age under the conditions prescribed, re£Jonimended, or suggested in the proposed 1 thereof; or (2)... | |
 | Administrative law - 1990 - 1086 pages
...stability, and bioavailability. (2) The investigations required under section 505(b) or 507 of the act do 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 its proposed... | |
 | United States - Agricultural laws and legislation - 1958 - 734 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...applicable to show whether or not such drug is safe for nse under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2)... | |
 | United States. Congress. Senate. Judiciary - Antitrust law - 1961 - 1928 pages
...market the product CARISOPRODOL until the parties have mutually ngrepd that said product CARISOPRODOL is safe for use under the conditions prescribed, recommended or suggested in the proposed labelling for the product, and will not market the product CARISOPRODOL without the written approval... | |
 | United States. Congress. Senate. Committee on the Judiciary - Antitrust law - 1961 - 1442 pages
...market the product CARIBOPRODOL until the parties have mutually agreed that said product CARISOPBODOL is safe for use under the conditions prescribed, recommended or suggested in the proposed labelling for the product, and will not market the product CARISOPRODOL without the written approval... | |
| |
... (A) the 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 applicable to show whether or not such drug is safe for use under the conditions... 
