 | Administrative law - 1990 - 1086 pages
...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... | |
 | Administrative law - 1998 - 1120 pages
...the effec-tiveness of the drug involved, on the basis of which it could fairly and re-sponsibly be concluded by such experts that the drug will have...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 - 1996 - 1130 pages
...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... | |
 | Administrative law - 1999 - 596 pages
...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... | |
 | Administrative law - 1982 - 900 pages
...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... | |
 | Administrative law - 1999 - 372 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...the conditions of use prescribed, recommended, or suggested in its proposed labeling. (6) The proposed labeling is false or misleading in any particular.... | |
 | Administrative law - 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...the conditions of use prescribed, recommended, or suggested in its proposed labeling. (6) The proposed labeling is false or misleading in any particular.... | |
 | Administrative law - 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.... | |
 | Administrative law - 1989 - 764 pages
...by such experts that the new animal drug will have the effect it Food and Drug Administration, HHS purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling. (iii) An application may be refused unless it contains detailed... | |
 | Administrative law - 1980 - 874 pages
...NRC panels. (b) The indications mentioned in the following categories refer to "the effect the drug purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling." That is, the indications are the claims noted in the labeling... | |
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... 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... 
