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Książki Książki 110 z 42 na temat ... (A) the investigations, reports of which are required to be submitted to the....
" ... (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... "
Decisions of the Commissioner of Patents and of the United States Courts in ... - Strona 38
autor: United States. Patent Office - 1964
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Notices of Judgment Under the Federal Food, Drug, and ..., Wydania 5501-7120

United States. Food and Drug Administration - 1959
...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...
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United States Code: Containing the General and Permanent Laws of the United ...

United States - 1977
...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...
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Miscellaneous Publication, Wydanie 1

United States. Food and Drug Administration - 1947
...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...
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The Code of Federal Regulations of the United States of America

1979
...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...
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The Code of Federal Regulations of the United States of America

1979
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1974
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1995
...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)...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1990
...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...
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The Code of Federal Regulations of the United States of America

1979
...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1980
...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 pro posed labeling. (ii) An application...
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