 | United States - Law - 1977 - 1276 pages
...subparagraph (A))— (i) which is sufficient to determine the effectiveness of a device, and (ii) 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,... | |
 | Administrative law - 1990 - 198 pages
...by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and responsibly be concluded by such experts that the drug is safe and effective for such uses; or (c) For which there exists substantial... | |
 | Administrative law - 1981 - 254 pages
...by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and responsibly be concluded by such experts that the drug is safe and effective for such uses; or (c) For which there exists substantial... | |
 | Administrative law - 1997 - 200 pages
...scientific training and experience to evaluate the safety and effectiveness of the drug in-volved, on the basis of which it can fairly and responsibly be concluded by such experts that the drug is safe and effective for such uses; or (c) For which there exists substantial... | |
 | Administrative law - 2001 - 242 pages
...by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and responsibly be concluded by such experts that the drug is safe and effective for such uses; or (c) For which there exists substantial... | |
 | Administrative law - 1964 - 1242 pages
...adequate and well-controlled investigations, Including clinical investigations, by medical experts, on the basis of which it can fairly and responsibly be concluded that the drug is effective for such purposes. The advertisement shall present information concerning... | |
 | Administrative law - 1988 - 590 pages
...conducted by qualified experts, and reports of significant human experience with a marketed device, from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.... | |
 | United States. Congress. House. Committee on Government Operations - Drugs - 1964 - 844 pages
...by scientific training and experience to evaluate the safety and effectiveness of the drug involved, on the basis of which it can fairly and responsibly be concluded by such experts that the drug is safe and effective for such uses ; or (3) For which there exists substantial... | |
 | Administrative law - 1964 - 1784 pages
...adequate and well-controlled investigations, including clinical investigations, by medical experts, on the basis of which it can fairly and responsibly be concluded that the drug is effective for such purposes. The advertisement shall present information concerning... | |
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For which there exists substantial clinical experience (as used in this section this means substantial clinical experience adequately documented in medical literature or by other data (to be supplied to the Food and Drug Administration... 
