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" ... there is a lack of substantial evidence that the drug will have the effect it purports or is represented to have... "
United States Code - Page 1141
by United States - 1964
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United States Code, Volume 6

United States - 1977 - 1276 pages
...drug, evaluated together with the evidence available to him •when the application was approved, that there is a lack of substantial evidence that the drug...the conditions of use prescribed, recommended, or suggested in the labeling thereof; or (4) that the application contains any untrue statement of a material...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1981 - 1252 pages
...to the drug, evaluated together with the evidence available when the application was approved, that there is a lack of substantial evidence that the drug...the conditions of use prescribed, recommended, or suggested in the labeling thereof (the provisions of § 314.111(a)(5) apply to the meaning of "substantial...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1974 - 402 pages
...(5) There is a lack of substantial evidence based upon adequate and well-controlled investigations that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy the following criteria : (i> A clear statement...
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The Code of Federal Regulations of the United States of America

1977 - 568 pages
...(5) There is a lack of substantial evidence based upon adequate and well-controlled investigations that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling thereof. An adequate and well-controlled investigation must satisfy the following criteria : (i) A clear statement...
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The Code of Federal Regulations of the United States of America

1969 - 668 pages
...the drug 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...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...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1982 - 900 pages
...the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the...
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Code of Federal Regulations: Containing a ..., Issue 21, Parts 500-599

1993 - 640 pages
...the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or...recommended, or suggested in the proposed labeling. (ii) The following principles have been developed over a period of years and are recognized by the...
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Code of Federal Regulations: Containing a Codification of Documents of ...

1999 - 596 pages
...the drug involved, on the basis of which it could fairly and reasonably be concluded by such experts that the drug will have the effect it purports or...the conditions of use prescribed, recommended, or suggested in the labeling or proposed labeling thereof. (6) Failure to include an appropriate proposed...
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Drug Safety, Part 5

United States. Congress. House. Committee on Government Operations - 1964 - 540 pages
...such drug evaluated together with the evidence available when the application was approved show that there is a lack of substantial evidence that the drug...the conditions of use prescribed, recommended, or suggested in the labeling thereof, in that: New evidence concerning the clinical investigations of...
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Drug Safety: Hearings Before a Subcommittee of the Committee on Government ...

United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...effectiveness. Also, after October 10, 1964, we may withdraw approval of a new drug application if "there is a lack of substantial evidence that the...the effect it purports or is represented to have" (from sec. 505 (e) of the Food, Drug, and Cosmetic Act). THE RISK Dramatic advances in medical science...
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