... evidence consisting of adequate and well-controlled investigations, including clinical investigations, by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which it could fairly... Drug Safety - Page 642by United States. Congress. House. Committee on Government Operations - 1964Full view - About this book
| United States - 1977 - 1276 pages
...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 is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; (F) upon the basis of the information submitted to him... | |
| 1987 - 996 pages
...consisting of adequate and wellcontrolled investigations, as defined in § 314.126, that the drug product will have the effect it purports or is represented...of use prescribed, recommended, or suggested in its proposed labeling. (6) The proposed labeling is false or misleading in any particular. (7) The application... | |
| 1988 - 772 pages
...involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period... | |
| 1977 - 1080 pages
...available when the application was approved, that there is a lack of substantial evidence that the drug will have the effect it purports or is represented...the conditions of use prescribed, recommended, or suggested in the labeling thereof (the provisions of § 314.111 (a) (5) apply to the meaning of "substantial... | |
| 1991 - 1218 pages
...well-controlled investigations as defined in § 314.126, that the drug will have the effect it is purported or is represented to have under the conditions of...prescribed, recommended, or suggested in its labeling; or (iv) That the application contains any untrue statement of a material fact. (b) FDA may notify the... | |
| 1992 - 744 pages
...available to him when the application was approved, there is a lack of substantial evidence that such drug will have the effect it purports or is represented to have under the conditions of Food and Drug Administration, HHS use prescribed, recommended, or suggested in the labeling thereof.... | |
| 1998 - 1120 pages
...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 to have under the conditions prescribed, rec-ommended, or suggested in the labeling or proposed labeling thereof." This def-inition... | |
| 1999 - 372 pages
...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 to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling thereof." This definition... | |
| 2002 - 384 pages
...wellcontrolled investigations as defined in §314.126, that the drug will have the effect it is purported or represented to have under the conditions of use prescribed, recommended, or suggested in its labeling; or (iv) That the application or abbreviated application contains any untrue statement of a material... | |
| 1994 - 1074 pages
...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 to have under the conditions prescribed, recommended, or suggested in the labeling or proposed labeling there§314.420 of." This... | |
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