 | 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 - 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 - 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... | |
 | 2002 - 628 pages
...1975, as amended at 50 FR 7517, Feb. 22, 1985; 50 FR 16668. Apr. 26, 1985; 62 FR 40600, July 29, 1997] §514.111 Refusal to approve an application. (a) The...for use under such conditions or do not show that §514.111 such drug is safe for use under such conditions; or (3) The methods used in and the facilities... | |
 | 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... | |
 | 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... | |
 | 1963 - 1386 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... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...(1) The investigations, reports of which are required to be submitted pursuant to section r>0r>(h) of the act. do not include adequate tests by all methods...prescribed, recommended, or suggested in the proposed Inbelins thereof : or (2) The results of such tests show that such drug is unsafe for use under such... | |
 | United States. Congress. House Interstate and Foreign Commerce - 1966 - 574 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... | |
| |
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... 
