 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...  Committee Prints - 411. lappuseautors: United States. Congress. Senate. Committee on Labor and Public Welfare - 1969Pilnskats - Par šo grāmatu
 | 1974 - 402 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...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy... | |
 | 1994 - 1074 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling there§314.420 of." This... | |
 | 1990 - 1086 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have...purports or is represented to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
 | 1964 - 1242 lapas
...adequate and well-controlled Investigations, Including clinical Investigations, by experts qualified by scientific training and experience to evaluate the...Involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented... | |
 | 1977 - 1080 lapas
...adequate and well-controlled Investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the...Involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or Is represented... | |
 | 1998 - 1120 lapas
...adequate and well-controlled Investigations, Including clinical Investigations, by experts qualified by scientific training and experience to evaluate the...involved, on the basis of which it could fairly and re-sponsibly be concluded by such experts that the drug will have the effect It purports or is represented... | |
 | 1981 - 1252 lapas
...adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the...involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have the effect it purports or is represented... | |
 | 1982 - 900 lapas
...the basis of which it could fairly and reasonably be concluded by such experts that the new animal drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (iii) An application may be refused unless it contains detailed... | |
 | 1999 - 596 lapas
...the basis of which it could fairly and reasonably be concluded by such experts that the new animal drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (iii) An application may be refused unless it contains detailed... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 lapas
...evaluate the effectiveness of the drug involved, on the basis of which it could fairly and responsibly be concluded by such experts that the drug will have...the conditions of use prescribed, recommended, or suggested in the proposed labeling. c. The complete composition and/or method of manufacture of the... | |
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