 | United States. Patent Office - 1964 - 972 pages
...conditions prescribed, recommended, or suggested In the proposed labeling thereof; (2) the results of such tests show that such drug Is unsafe for use...that such drug Is safe for use under such conditions; (3) the methods used In, and the facilities and controls used for, the manufacture, processing, and... | |
 | 1939 - 1496 pages
...conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use...that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and... | |
 | United States - 1977 - 1276 pages
...conditions prescribed, recommended, or suggested in the proposed labeling thereof; (B) the results of such tests show that such drug is unsafe for use...that such drug is safe for use under such conditions; (C) the methods used in, and the facilities and controls used for, the manufacture, processing, and... | |
 | United States - 1964 - 1098 pages
...conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use...that such drug is safe for use under such conditions; (3) the methods used in, and the facilities and controls used for, the manufacture, processing, and... | |
 | 1978 - 860 pages
...the Commissioner determine upon the basis of the application, or upon the basis of other informatiet before him with respect to the new drug, that: (1)...processing, and packing of such drug are inadequate to pieserve its identity, strength, quality, and purity; or (4) Upon the basis of the information submitted... | |
 | 1974 - 402 pages
...conditions prescribed, recommended, or suggested In the proposed labeling thereof ; or (2) The results of such tests show that such drug is unsafe for use...for, the manufacture, processing, and packing of such drugs are Inadequate to preserve its Identity, strength, quality, and purity; or (4) There is insufficient... | |
 | United States. Congress. House. Committee on Interstate and Foreign Commerce - 1962 - 734 pages
...such conditions or do not show that such drug is safe and efficacious for use under such conditions; (3) the methods used in, and the facilities and controls...preserve its identity, strength, quality, [and] purity, safety, and efficacy; or (4) upon the basis of the information submitted to him as part of the application,... | |
 | United States. Congress. House. Interstate and Foreign Commerce - 1962 - 732 pages
...such conditions or do not show that such drug is safe and efficacious for use under such conditions; (3) the methods used in, and the facilities and controls...preserve its identity, strength, quality, [and] purity, safety, and efficacy; or (4) upon the basis of the information submitted to him as part of the application,... | |
 | 1963 - 1386 pages
...conditions prescribed, recommended, or suggested in the proposed labeling thereof; (b) The results of such tests show that such drug is unsafe for use...that such drug is safe for use under such conditions; (c) The methods used in, and the fa-cilities and controls used for, the manufacture, processing, and... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...conditions prescribed, recommended, or suggested in the proposed Inbelins thereof : or (2) The results of such tests show that such drug is unsafe for use...or do not show that such drug is safe for use under stich conditions: or (3) The methods used in, and the facilities and controls used for, the manufacture,... | |
| |
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 thereof; (2)... 
