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 56
... studies con- ducted in a manner which is consistent with generally recognized scientific procedures and principles ) , that there is significant sci- entific agreement , among experts qualified by scientific training and experience to ...
... studies con- ducted in a manner which is consistent with generally recognized scientific procedures and principles ) , that there is significant sci- entific agreement , among experts qualified by scientific training and experience to ...
Page 59
... studies con- ducted in a manner which is consistent with generally recognized scientific procedures and principles ) , that there is significant sci- entific agreement , among experts qualified by scientific training and experience to ...
... studies con- ducted in a manner which is consistent with generally recognized scientific procedures and principles ) , that there is significant sci- entific agreement , among experts qualified by scientific training and experience to ...
Page 59
... studies con- ducted in a manner which is consistent with generally recognized scientific procedures and principles ) , that there is significant sci- entific agreement , among experts qualified by scientific training and experience to ...
... studies con- ducted in a manner which is consistent with generally recognized scientific procedures and principles ) , that there is significant sci- entific agreement , among experts qualified by scientific training and experience to ...
Page 71
... studies ; ( iii ) available information concerning the relation- ship of the results of such studies to human risk ; ( iv ) available information concerning the dietary consumption patterns of consumers ( and major identi- fiable ...
... studies ; ( iii ) available information concerning the relation- ship of the results of such studies to human risk ; ( iv ) available information concerning the dietary consumption patterns of consumers ( and major identi- fiable ...
Page 128
... studies has been sub- mitted under this subsection for the drug with respect to which the certification is made to obtain approval to en- gage in the commercial manufacture , use , or sale of the drug before the expiration of the patent ...
... studies has been sub- mitted under this subsection for the drug with respect to which the certification is made to obtain approval to en- gage in the commercial manufacture , use , or sale of the drug before the expiration of the patent ...
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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