| United States - Law - 1977 - 1276 pages
...respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions...recommended, or suggested in the proposed labeling thereof; (F) upon the basis of the information submitted to him as part of the application or any other... | |
| United States - Law - 1964 - 1098 pages
...respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions...recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts, such labeling is false or misleading... | |
| Administrative law - 1988 - 720 pages
...judgment of the members of NAS-NRC panels. (b) The indications mentioned in the following categories refer to "the effect the drug purports or is represented...recommended, or suggested in the proposed labeling." That is, the indications are the claims noted 48 CFR Ch. 3 (10-1-88 Edition) in the labeling of a given... | |
| Administrative law - 1980 - 874 pages
...of the members of NAS— NRC panels. (b) The indications mentioned in the following categories refer to "the effect the drug purports or is represented...recommended, or suggested in the proposed labeling." That is, the indications are the claims noted in the labeling of a given drug product. (1) Category... | |
| Administrative law - 1985 - 592 pages
...judgment of the members of NAS-NRC panels. (b) The indications mentioned in the following categories refer to "the effect the drug purports or is represented...recommended, or suggested in the proposed labeling." That is, the indications are the claims noted PHS 380.304-2 in the labeling of a given drug product.... | |
| Administrative law - 1981 - 730 pages
...which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or is represented to have under the conditions...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the... | |
| Administrative law - 1978 - 618 pages
...fairly and reasonably be concluded by such experts that the new animal drug will have the effect it purports or is represented to have under the conditions...recommended, or suggested in the proposed labeling. (ill) An application may be refused unless it contains detailed reports of the investigations, including... | |
| United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 540 pages
...referred to in these definitions correspond with the reference that is made in the law to "the effects the drug purports or is represented to have under...claims that are cited in the labeling of a given drug. B. Justification (Item 9) A Panel is expected to support each recommendation with a brief statement... | |
| United States - Public health laws - 1966 - 556 pages
...respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions...recommended, or suggested in the proposed labeling thereof; or (6) based on a fair evaluation of all material facts, such labeling is false or misleading... | |
| United States. Congress. House. Interstate and Foreign Commerce - 1966 - 82 pages
...respect to such drug, there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have under the conditions...recommended, or suggested in the proposed labeling thereof ; "(IT) upon the basis of the information submitted to him as part of the application or any... | |
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