| United States. Patent Office - 1964 - 972 페이지
...Secretary finds, after due notice to the applicant and giving him an opportunity for a hearing, that (1) the Investigations, reports of which are required...submitted to the Secretary pursuant to subsection (b) of this section, do not Include adequate tests by all methods reasonably applicable to show whether... | |
| 1939 - 1496 페이지
...Secretary finds, after due notice to the applicant and giving him an opportunity for a hearing, that (1) the investigations, reports of which are required...reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling... | |
| United States - 1977 - 1276 페이지
...(c) of this section and giving him an opportunity for a hearing, in accordance with said subsection, that— (A) the investigations, reports of which are...submitted to the Secretary pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably applicable to show whether... | |
| United States - 1964 - 1098 페이지
...this section and giving him an opportunity for a hearing, in accordance with said subsection, that il) the investigations, reports of which are required...submitted to the Secretary pursuant to subsection (b) of this section, do not include adequate tests by all methods reasonably applicable to show whether... | |
| 1995 - 616 페이지
...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 use under the conditions prescribed, recommended, or suggested in the proposed labeling... | |
| 1974 - 402 페이지
...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 use under the conditions prescribed, recommended, or suggested In the proposed labeling... | |
| 1992 - 744 페이지
...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 use under the conditions prescribed, recommended, or suggested in the proposed labeling... | |
| 1990 - 1086 페이지
...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 페이지
...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... | |
| 1958 - 342 페이지
...of the application, or upon the basis of other information before him with respect to the new drug, 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 reasonably applicable... | |
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