 | 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
...section and giving him an opportunity for a hearing, in accordance with said subsection, that— (A) the investigations, reports of which are required...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 - 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... | |
 | 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... | |
 | 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... | |
 | 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... | |
 | 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)... | |
 | 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... | |
 | 1988 - 772 pages
...establish safety and effectiveness, (i) An application may be refused unless it contains full reports of adequate tests by all methods reasonably applicable to show whether or not the new animal drug is safe and effective for use as suggested in the proposed labeling. Ш) An application... | |
| |
... (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... 
