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 19
( i ) that the manufacturer or distributor conducted , before the institution of a criminal proceeding against such represent- ative for the violation which resulted in such conviction , an investigation of events or transactions which ...
( i ) that the manufacturer or distributor conducted , before the institution of a criminal proceeding against such represent- ative for the violation which resulted in such conviction , an investigation of events or transactions which ...
Page 26
... conducted by such officer or qualified employee , if the officer or qualified employee has credible evidence or information indicating that such arti- cle presents a threat of serious adverse health con- sequences or death to humans or ...
... conducted by such officer or qualified employee , if the officer or qualified employee has credible evidence or information indicating that such arti- cle presents a threat of serious adverse health con- sequences or death to humans or ...
Page 28
... conduct that- ( I ) relates to the development or approval , in- cluding the process for the development or ap- proval , of any abbreviated drug application ; and ( II ) is a felony under Federal law ( if the per- son was convicted ...
... conduct that- ( I ) relates to the development or approval , in- cluding the process for the development or ap- proval , of any abbreviated drug application ; and ( II ) is a felony under Federal law ( if the per- son was convicted ...
Page 29
... conduct suffi- cient to find that there is reason to believe that such individual may violate requirements under this Act re- lating to drug products . ( iii ) Any individual whom the Secretary finds materially participated in acts that ...
... conduct suffi- cient to find that there is reason to believe that such individual may violate requirements under this Act re- lating to drug products . ( iii ) Any individual whom the Secretary finds materially participated in acts that ...
Page 35
... conduct described in subparagraph ( B ) of subsection ( f ) ( 1 ) in connection with 2 or more drugs under ... conduct described in subparagraph ( A ) , the Secretary shall issue an order suspending the distribution of all drugs the ...
... conduct described in subparagraph ( B ) of subsection ( f ) ( 1 ) in connection with 2 or more drugs under ... conduct described in subparagraph ( A ) , the Secretary shall issue an order suspending the distribution of all drugs the ...
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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