 Secretary until after such application was approved, or tests by new methods, or tests by methods not deemed reasonably applicable when such application was approved, evaluated...  Drug Industry Antitrust Act, 87-1&2 - Page 907by United States. Congress. Senate. Judiciary - 1961Full view - About this book
 | 1939 - 1496 pages
...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... | |
 | United States - 1977 - 1276 pages
...that clinical or other experience, tests, or other scientific data show that such drug is unsafe for use under the conditions of use upon the basis of which the application was approved; (2) that new evidence of clinical experience, not contained in such application... | |
 | 1998 - 1120 pages
...appli-cation or abbreviated application wu approved, reveal that the drug IB 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... | |
 | 2002 - 628 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... | |
 | United States. Congress. Senate. Committee on the Judiciary - 1961 - 754 pages
...deemed reasonably applicable when such application became effective" show the drug to be unsafe for use under the conditions of use upon the basis of which the application became effective. The bill would amend this subsection only to permit suspension of a new-drug... | |
 | United States. Congress. House. Interstate and Foreign Commerce - 1962 - 732 pages
...inefficacious, or show that there is substantial doubt as to the safety or efficacy of such drug, for use under the conditions of use upon the basis of which the application was approved, or (2) that the application contains any untrue statement of a material fact,... | |
 | United States. Congress. House. Committee on the Judiciary - 1962 - 938 pages
...deemed reasonably applicable when such application became effective" .show the drug to be unsafe for use under the conditions of use upon the basis of which the application became effective. The bill would amend this subsection only to permit suspension of a new-drug... | |
 | United States. Congress. House. Committee on the Judiciary - 1962 - 934 pages
...deemed reasonably applicable when such application became effective" show the drug to be unsafe for use under the conditions of use upon the basis of which the application became effective. The bill would amend this subsection only to permit suspension of a new-drug... | |
 | United States. Congress. House. Committee on Government Operations - 1964 - 844 pages
...evidence available when the 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 was approved ; or (3) Upon the basis of new information before the Food and Drug Administration... | |
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