 | United States - Law - 1977 - 1276 pages
...it can fairly and responsibly be concluded by qualified experts that the device will have the effect question whether such application is approvable. If the applicant elects to accept the oppor suggested in the labeling of the device, then, for purposes of this section and sections 360d and 360e... | |
 | Administrative law - 1974 - 402 pages
...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...recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy the following criteria : (i> A clear statement... | |
 | Administrative law - 1977 - 1080 pages
...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...recommended, or suggested In the proposed labeling. c. Reports of all clinical tests sponsored by the applicant or received or otherwise obtained by the... | |
 | Administrative law - 1988 - 772 pages
...could 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. (iii) An application may be refused unless it contains detailed reports of the investigations, including... | |
 | 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...recommended, or suggested in the proposed labeling. (iii) An application may be refused unless it contains detailed reports of the investigations, including... | |
 | 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...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 - 1965 - 1520 pages
...to have under the conditions of use prescribed, recommended, or suggested in the proposed labeling: or (6) Based on a fair evaluation of all material facts, such labeling is false or misleading in any particular ; the Commissioner shall within 180 days after the filing of the application inform the... | |
 | Administrative law - 1985 - 592 pages
...NAS-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...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 - 1252 pages
...experience, and reports lacking the details which permit scientific evaluation will not be considered. (6) Based on a fair evaluation of all material facts, such labeling is false or misleading in any particular; or (7) The applicant fails to submit an environmental impact analysis report analyzing... | |
 | Administrative law - 1996 - 618 pages
...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 use prescribed, recommended, or suggested in the labeling thereof. (4) That any nonclinical laboratory study that is described in the... | |
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... 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 and responsibly be concluded by such experts that... 
