 Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness...  Drug Safety - Page 1317by United States. Congress. House. Committee on Government Operations - 1964Full view - About this book
 | United States - Law - 1964 - 1098 pages
...any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts,... | |
 | United States - Law - 1977 - 1276 pages
...any other information before him with respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; (F) upon the basis of the information submitted to him... | |
 | Administrative law - 1964 - 1242 pages
...to the Food and Drug Administration. b. An application may be refused unless It Includes substantial evidence consisting of adequate and well-controlled...the conditions of use prescribed, recommended, or suggested In the proposed labeling. c. The complete composition and/or method of manufacture of the... | |
 | Administrative law - 1981 - 1252 pages
...information before the Food and Drug Administration with respect to such drug, there is lack of substantial evidence consisting of adequate and well-controlled...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period... | |
 | Administrative law - 1986 - 1610 pages
...adequately ensure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | Administrative law - 1998 - 1162 pages
...adequately ensure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | Administrative law - 1990 - 1086 pages
...adequately ensure safety and efficacy of use. "Substantial evidence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | Administrative law - 1998 - 1120 pages
...adequately ensure safety and efficacy of use. "Substantial evi-dence" has been defined by Congress to mean "evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions prescribed, rec-ommended, or suggested in the labeling or proposed labeling thereof." This def-inition... | |
 | Administrative law - 1977 - 1080 pages
...may be refused unless It Includes substantial evidence consisting of adequate and well -con trolled Investigations, Including clinical Investigations,...the conditions of use prescribed, recommended, or suggested In the proposed labeling. c. Reports of all clinical tests sponsored by the applicant or... | |
 | Administrative law - 1965 - 1520 pages
...investigations, including clinical investigations, by experts qualified by scientific training ar.d experience to evaluate the effectiveness of the drug...the conditions of use prescribed, recommended, or suggested in the proposed labeling: or (6) Based on a fair evaluation of all material facts, such labeling... | |
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