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 34
... practice of false statements or misrepresen- tations with respect to material facts relating to any abbreviated drug application , or the production of any drug subject to an abbreviated drug application , to any officer , employee , or ...
... practice of false statements or misrepresen- tations with respect to material facts relating to any abbreviated drug application , or the production of any drug subject to an abbreviated drug application , to any officer , employee , or ...
Page 35
... practice or good laboratory practice in connection with the development , manufacturing , or distribution of one or more drugs approved under an abbreviated drug application during a 2 - year period , and— ( I ) such violations may ...
... practice or good laboratory practice in connection with the development , manufacturing , or distribution of one or more drugs approved under an abbreviated drug application during a 2 - year period , and— ( I ) such violations may ...
Page 40
... practice set forth in the abbreviated drug application and has introduced , or attempted to intro- duce , such adulterated or misbranded drug into commerce . ( b ) PROCEDURE . - The Secretary may not take any action under subsection ( a ) ...
... practice set forth in the abbreviated drug application and has introduced , or attempted to intro- duce , such adulterated or misbranded drug into commerce . ( b ) PROCEDURE . - The Secretary may not take any action under subsection ( a ) ...
Page 44
... practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology . No standard of cur- rent good manufacturing practice may be imposed unless such standard is ...
... practice regulations for food and may not impose standards for which there is no current and generally available analytical methodology . No standard of cur- rent good manufacturing practice may be imposed unless such standard is ...
Page 46
... practice , " ( a ) " is a subsection , " ( 1 ) ” is a para- graph , “ ( A ) ” is a subparagraph , “ ( i ) ” is a ... practice . In modern practice , all of the section 403 text would be considered an undesignated sub- section , and the ...
... practice , " ( a ) " is a subsection , " ( 1 ) ” is a para- graph , “ ( A ) ” is a subparagraph , “ ( i ) ” is a ... practice . In modern practice , all of the section 403 text would be considered an undesignated sub- section , and 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