 ... consisting of adequate and well-controlled Investigations, Including clinical Investigations, by experts qualified by scientific training and experience to evaluate the effec-tiveness of the drug involved, on the basis of which it could fairly and...  Medical Devices: Hearings, Ninety-third Congress, First Session ... - Page 218by United States. Congress. House. Committee on Interstate and Foreign Commerce. Subcommittee on Public Health and Environment - 1974 - 446 pagesFull view - About this book
 | 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 - 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... | |
 | Administrative law - 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... | |
 | Administrative law - 1998 - 1162 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... | |
 | United States. Congress. Senate. Government Operations - 1962 - 1078 pages
...on the basis of could fairly and respon-sibly be concluded by such experts that the drug trif/ *IK the effect it purports, or is represented to have under the conditions of utf prescribed, recommended, or suggested in the labeling or proposed labeling therm!" (A professional... | |
 | United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 650 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 of n-<e proscribed, recommended, or suggested in the labeling or proposed labeling thereof." I interpret... | |
 | United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 1600 pages
...involved. • the basis of which it could fairly and responsibly be concluded by such esp?:" that the drug will have the effect it purports or is represented to have under ;b conditions of use proscribed, recommended, or suggested in the labeling or K posed labeling thereof."... | |
 | Consumer protection - 1969 - 454 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." In every case,... | |
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