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 9
... subparagraph ( 2 ) , with separate indentation , to indicate the probable intent of the Congress , although such placement of matter that is not a complete sentence calls for striking the period at the end of subparagraph ( 2 ) and ...
... subparagraph ( 2 ) , with separate indentation , to indicate the probable intent of the Congress , although such placement of matter that is not a complete sentence calls for striking the period at the end of subparagraph ( 2 ) and ...
Page 32
... subparagraph does not constitute an amend- ment or supplement to pending or approved abbreviated drug applications . ( B ) CORPORATIONS . - Upon an application submitted under subparagraph ( A ) , the Secretary may take the ac- tion ...
... subparagraph does not constitute an amend- ment or supplement to pending or approved abbreviated drug applications . ( B ) CORPORATIONS . - Upon an application submitted under subparagraph ( A ) , the Secretary may take the ac- tion ...
Page 33
... subparagraph ( A ) , the Secretary may take the ac- tion described in subparagraph ( D ) if the Secretary , after an informal hearing , finds that such individual has pro- vided substantial assistance in the investigations or pros ...
... subparagraph ( A ) , the Secretary may take the ac- tion described in subparagraph ( D ) if the Secretary , after an informal hearing , finds that such individual has pro- vided substantial assistance in the investigations or pros ...
Page 34
... subparagraph ( A ) , the Secretary determines that a per- son has been criminally charged for an action described in subparagraph ( B ) of paragraph ( 1 ) , the Secretary may ex- tend the period of denial of approval of an application ...
... subparagraph ( A ) , the Secretary determines that a per- son has been criminally charged for an action described in subparagraph ( B ) of paragraph ( 1 ) , the Secretary may ex- tend the period of denial of approval of an application ...
Page 35
... subparagraph ( B ) of subsection ( f ) ( 1 ) in connection with 2 or more drugs under abbreviated drug applica ... subparagraph ( A ) , the Secretary shall issue an order suspending the distribution of all drugs the development or ...
... subparagraph ( B ) of subsection ( f ) ( 1 ) in connection with 2 or more drugs under abbreviated drug applica ... subparagraph ( A ) , the Secretary shall issue an order suspending the distribution of all drugs the development 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