Compilation of Selected Acts Within The Jurisdiction of The Committee on Energy and Commerce, March 2005, 109-1 Committee Print 109-A, *2005 |
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Page 140
... listed drug ; ( II ) if the listed drug referred to in clause ( i ) has more than one active ingredient , information to show that the active ingredients of the new drug are the same as those of the listed drug , or ( III ) if the listed ...
... listed drug ; ( II ) if the listed drug referred to in clause ( i ) has more than one active ingredient , information to show that the active ingredients of the new drug are the same as those of the listed drug , or ( III ) if the listed ...
Page 141
... listed drug referred to in clause ( i ) or , if the route of administration , the dosage form , or the strength of the new drug is different and the application is filed pursu- ant to the approval of a petition filed under subparagraph ...
... listed drug referred to in clause ( i ) or , if the route of administration , the dosage form , or the strength of the new drug is different and the application is filed pursu- ant to the approval of a petition filed under subparagraph ...
Page 142
... listed drug , such person shall submit a petition to the Secretary seeking permission to file such an application . The Secretary shall approve or disapprove a petition submitted under this subpara- graph within ninety days of the date ...
... listed drug , such person shall submit a petition to the Secretary seeking permission to file such an application . The Secretary shall approve or disapprove a petition submitted under this subpara- graph within ninety days of the date ...
Page 143
... listed drug " for purposes of this subparagraph . ( 3 ) ( A ) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph ( 1 ) , which shall relate to promptness in conducting the review ...
... listed drug " for purposes of this subparagraph . ( 3 ) ( A ) The Secretary shall issue guidance for the individuals who review applications submitted under paragraph ( 1 ) , which shall relate to promptness in conducting the review ...
Page 143
... listed drug , such person shall submit a petition seeking permission to file such an application . approve or disapprove a petition submitted GAS aph within ninety days of the date the petiti y shall approve such a petition the S cation ...
... listed drug , such person shall submit a petition seeking permission to file such an application . approve or disapprove a petition submitted GAS aph within ninety days of the date the petiti y shall approve such a petition the S cation ...
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Common terms and phrases
action active ingredient amendment animal drug application animal feed appropriate approved new animal Attorney authorized bioequivalence cation certification classification clause clause iv clinical containing controlled substance court described dispensing distribution dosage form drug or device drug product ecgonine electronic product enactment established exemption expiration Federal Food Federal Register filed fiscal Food and Drug graph Health Service Act infant formula investigational issued labeling licensed listed chemical listed drug manufacturer ment notice notification panel paragraph patent period person pesticide petition phenylpropanolamine premarket prescribed proposed pseudoephedrine Public Law purposes referred registration regulation request respect retary route of administration safety and effectiveness safety or effectiveness schedule III Secretary determines Secretary finds section 351 sentence specified spect standard subchapter subclause submitted subparagraph substance in schedule supplement term of imprisonment tion United States Code United States Pharmacopoeia unless violation