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 27
... INDIVIDUALS . - If the Secretary finds that an individual has been convicted of a felony under Federal law for conduct- ( A ) relating to the development or approval , including the process for development or approval , of any drug prod ...
... INDIVIDUALS . - If the Secretary finds that an individual has been convicted of a felony under Federal law for conduct- ( A ) relating to the development or approval , including the process for development or approval , of any drug prod ...
Page 28
... individual from submitting or assisting in the submission of any abbreviated drug ap- plication , ( B ) an individual from providing services in any capac- ity to a person that has an approved or pending drug prod- uct application , or ...
... individual from submitting or assisting in the submission of any abbreviated drug ap- plication , ( B ) an individual from providing services in any capac- ity to a person that has an approved or pending drug prod- uct application , or ...
Page 29
... individual and other information , that such indi- vidual has demonstrated a pattern of conduct suffi- cient to find that there is reason to believe that such individual may violate requirements under this Act re- lating to drug ...
... individual and other information , that such indi- vidual has demonstrated a pattern of conduct suffi- cient to find that there is reason to believe that such individual may violate requirements under this Act re- lating to drug ...
Page 30
... individual from pro- viding services in any capacity to a person that has an ap- proved or pending drug product application and shall not accept or review ( other than in connection with an audit under this section ) an abbreviated drug ...
... individual from pro- viding services in any capacity to a person that has an ap- proved or pending drug product application and shall not accept or review ( other than in connection with an audit under this section ) an abbreviated drug ...
Page 32
... INDIVIDUALS.- ( i ) CONVICTION REVERSAL . - If the conviction which served as the basis for the debarment of an individual under subsection ( a ) ( 2 ) or clause ( i ) , ( ii ) , ( iii ) , or ( iv ) of subsection ( b ) ( 2 ) ( B ) or ...
... INDIVIDUALS.- ( i ) CONVICTION REVERSAL . - If the conviction which served as the basis for the debarment of an individual under subsection ( a ) ( 2 ) or clause ( i ) , ( ii ) , ( iii ) , or ( iv ) of subsection ( b ) ( 2 ) ( B ) or ...
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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