 | United States - 1977 - 1276 lapas
...As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal... | |
 | United States - 1964 - 1098 lapas
...As used in this subsection and subsection (e) of this section, the term "substantial evidence" means evidence consisting of adequate and wellcontrolled...drug involved, on the basis of which it could fairly TITLE 21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts that the drug will... | |
 | 1971 - 676 lapas
...have such characteristics of identity, strength, quality, and purity necessary to adequately insure safety and efficacy of use. "Substantial evidence"...concluded by such experts that the drug will have the effectiveness it purports and is represented to have under the conditions prescribed, recommended or... | |
 | 1981 - 1252 lapas
...have such characteristics of identity, strength, quality, and purity necessary to adequately insure safety and efficacy of use. "Substantial evidence"...concluded by such experts that the drug will have the effectiveness it purports and is represented to have under the conditions prescribed, recommended or... | |
 | 1978 - 860 lapas
...have such characteristics of identity, strength, quality, and purity necessary to adequately Insure safety and efficacy of use. Substantial evidence”...responsibly be concluded by such experts that the drug vill have the effectiveness It purports and is represented to have under the conditions prescribed,... | |
 | 1964 - 1242 lapas
...to the Food and Drug Administration. b. An application may be refused unless It Includes substantial evidence consisting of adequate and well-controlled...purports or is represented to have under the conditions of use prescribed, recommended, or suggested In the proposed labeling. c. The complete composition... | |
 | 1965 - 1520 lapas
...investigations, including clinical investigations, by experts qualified by scientific training ar.d experience to evaluate the effectiveness of the drug...purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling: or (6) Based on a fair evaluation... | |
 | 1969 - 668 lapas
...investigations, by experts qualified by scientific training and experience to evaluate the effectiveness §130.13 of the drug involved, on the basis of which it could...purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling; or (6) Based on a fair evaluation... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 1600 lapas
...REVISED AUGUST 1963) As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled...responsibly be concluded by such experts that the drug wil! have the effect it purports or is represented to have under the conditions of USP prescribed,... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 lapas
...Administration. b. An application may be incomplete or may be refused unless it includes substantial evidence consisting of adequate and well-controlled...which it could fairly and responsibly be concluded that the drug will have the effect it purports or is represented to have under the conditions of use... | |
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As used in this subsection and subsection (e), the term "substantial evidence" means evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate... 
