 | United States - 1964 - 1098 lapas
...21.— POOD AND DRUGS Page 1142 and responsibly be concluded by such experts 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 labeling or proposed labeling thereof. (e) Withdrawal of approval; grounds; immediate... | |
 | United States - 1977 - 1276 lapas
...from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under...the conditions of use prescribed, recommended, or suggested in the labeling of the device, then, for purposes of this section and sections 360d and 360e... | |
 | 1974 - 402 lapas
...substantial evidence based upon adequate and well-controlled investigations that the drug will have the effect it purports or is represented to have under...recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy the following criteria : (i> A clear statement... | |
 | 1997 - 580 lapas
...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 to have under...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the... | |
 | 1965 - 1520 lapas
...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... | |
 | 1980 - 874 lapas
...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... | |
 | 1989 - 764 lapas
...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... | |
 | 1985 - 592 lapas
...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.... | |
 | 1981 - 1252 lapas
...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... | |
 | 2002 - 384 lapas
...adequate and wellcontrolled investigations, as defined in §314.126, that the drug product will have the effect it purports or is represented to have under...the conditions of use prescribed, recommended, or suggested in its proposed labeling. (6) The proposed labeling is false or misleading in any particular.... | |
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... will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. 
