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 11
... Service Act . ( ee ) The term " Commissioner " means the Commissioner of Food and Drugs . ( ff ) The term " dietary supplement❞— ( 1 ) means a product ( other than tobacco ) intended to sup- plement the diet that bears or contains one ...
... Service Act . ( ee ) The term " Commissioner " means the Commissioner of Food and Drugs . ( ff ) The term " dietary supplement❞— ( 1 ) means a product ( other than tobacco ) intended to sup- plement the diet that bears or contains one ...
Page 38
... Services , a false statement or misrepresentation of a material fact in connection with an abbreviated drug application , ( 2 ) bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any officer , employee , or ...
... Services , a false statement or misrepresentation of a material fact in connection with an abbreviated drug application , ( 2 ) bribed or attempted to bribe or paid or attempted to pay an illegal gratuity to any officer , employee , or ...
Page 83
... service for the performance of the Administrator's functions under this section . Under the regulations , the performance of the Admin- istrator's services or other functions under this section , including― 1 Section 501 ( d ) ( 2 ) of ...
... service for the performance of the Administrator's functions under this section . Under the regulations , the performance of the Admin- istrator's services or other functions under this section , including― 1 Section 501 ( d ) ( 2 ) of ...
Page 110
... Service Act for such drug and is based on competent and reliable scientific evidence . The requirements set forth in section 505 ( a ) or in section 351 ( a ) of the Public Health Service Act shall not apply to health care economic ...
... Service Act for such drug and is based on competent and reliable scientific evidence . The requirements set forth in section 505 ( a ) or in section 351 ( a ) of the Public Health Service Act shall not apply to health care economic ...
Page 123
... Service Act ( 42 U.S.C. 262 ( i ) ) . ( C ) The term " market clearance " includes- ( i ) approval of an application under section 505 , 507 , 515 , or 520 ( g ) , ( ii ) a finding of substantial equivalence under this sub- chapter ...
... Service Act ( 42 U.S.C. 262 ( i ) ) . ( C ) The term " market clearance " includes- ( i ) approval of an application under section 505 , 507 , 515 , or 520 ( g ) , ( ii ) a finding of substantial equivalence under this sub- chapter ...
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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