 | James Beck, Anthony Vale - 2004 - 982 pages
...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; ... the results of such tests show that the drug is unsafe for use under the conditions prescribed,... | |
 | M.N.G. Dukes - 2005 - 422 pages
...efficacy and safety to be proven, the applicant being firmly obliged "to show whether such drug is safe for use under the conditions prescribed, recommended or suggested in the proposed labelling thereof "(Art 355d). The authorities were nevertheless entitled to withdraw their approval... | |
 | Ronald Hamowy - 2008 - 539 pages
...this. Among the duties imposed by the law on drug manufacturers was that each drug demonstrate that it was 'safe for use under the conditions prescribed, recommended or suggested in the proposed labeling thereof . The effect of this requirement was to impose on manufacturers the duty of labeling their... | |
 | 67 pages
...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 tests show that such drug is unsafe for use under such conditions... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 850 pages
...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 results of such tests show that such drug is unsafe for use under such conditions... | |
 | 1964 - 1248 pages
...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 results of such tests show that such drug Is unsafe for use under such conditions... | |
 | 362 pages
...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 if "the results of such tests show that such drug is unsafe for use under such conditions... | |
 | 1970 - 654 pages
...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 results of such tests show that such drug is unsafe for use under such conditions... | |
 | 1971 - 704 pages
...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 results of such tests show that such drug is unsafe for use under such conditions... | |
| |
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... 
