 | 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
...effectiveness of the 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...purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (e) Withdrawal... | |
 | 1995 - 1186 lapas
...proposing the issuance, amendment, or repeal of the regulation under the provisions of section 807(f) of the act and part 10. The Commissioner shall cause...the conditions prescribed, recommended, or suggested is the labeling or proposed labeling thereof." This definition is made applicable to a number of antibiotic... | |
 | 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... | |
 | 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... | |
 | 1977 - 1080 lapas
...purity necessary to adequately insure safety and efficacy of use. "Substantial evidence" has been denned by Congress to mean "evidence consisting of adequate...concluded by such experts that the drug will have the effectiveness it purports and is represented to have under the conditions prescribed, recommended or... | |
 | 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... | |
 | 1996 - 618 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have...purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles... | |
 | 1989 - 760 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have...purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles... | |
 | 1977 - 568 lapas
...(5) There is a lack of substantial evidence based upon adequate and well-controlled investigations that the drug will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled... | |
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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... 
