 | United States - 1939 - 1496 pages
...not deemed reasonably applicable when such application became effective show that such drug is unsafe for use under the conditions of use upon the basis of which the application became effective, or (2) that the application contains any untrue statement of a material fact. The... | |
 | United States - Law - 1977 - 1276 pages
...together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions...upon the basis of which the application was approved; or (3) on the basis of new information before him with respect to such drug, evaluated together with... | |
 | Administrative law - 1981 - 1252 pages
...approved, evaluated together with the evidence available when the application was approved, reveal that the drug is not shown to be safe for use under the...upon the basis of which the application was approved; or (3) Upon the basis of new information before the Food and Drug Administration with respect to the... | |
 | Administrative law - 1979 - 1056 pages
...approved, evaluated together with the evidence available when the application was approved, reveal that the drug is not shown to be safe for use under the...upon the basis of which the application was approved; or (3) Upon the basis of new information before the Pood and Drug Administration with respect to the... | |
 | Administrative law - 1981 - 730 pages
...together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions...upon the basis of which the application was approved or that section 512 (dXIXH) of the act applies to such drug; or (iii) On the basis of new information... | |
 | Administrative law - 1977 - 568 pages
...together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions...upon the basis of which the application was approved or that section 512 (dKlMH) of the act applies to such drug; or (ill) On the basis of new information... | |
 | Administrative law - 1982 - 900 pages
...together with the evidence available to the Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions...upon the basis of which the application was approved or that section 512 (dXIKH) of the act applies to such drug; or (iii) On the basis of new information... | |
 | Administrative law - 2002 - 384 pages
...with the evidence available when the application or abbreviated application was approved, reveal that the drug is not shown to be safe for use under the...conditions of use upon the basis of which the application or abbreviated application was approved; or (iii) Upon the basis of new information before FDA with... | |
 | Administrative law - 1998 - 1120 pages
...evidence available when the appli-cation or abbreviated application was approved, reveal that the drug 1 is not shown to be safe for use under the con-ditions of use upon the basis of which the application or abbreviated applica-tion was approved; or (ill) Upon the basis of new informa-tion before FDA with... | |
 | Administrative law - 1986 - 792 pages
...pursuant to section 512(c) of the act: (i) Experience or scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved; or (ii) New evidence not contained in such application or not available to the Secretary until after... | |
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Secretary when the application was approved, shows that such drug is not shown to be safe for use under the conditions of use upon the basis of which the application was approved... 
