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
... application , or the production of any drug subject to an abbreviated drug application , to any officer , employee , or agent of the Department of Health and Human Services , or has conspired to com- mit , or aided or abetted , such ...
... application , or the production of any drug subject to an abbreviated drug application , to any officer , employee , or agent of the Department of Health and Human Services , or has conspired to com- mit , or aided or abetted , such ...
Page 127
... application the patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent ...
... application the patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent ...
Page 127
... application the patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent ...
... application the patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent ...
Page 130
... application under subsection ( b ) , or such additional period as may be agreed upon by the Secretary and the applicant , the Secretary shall either- ( A ) approve the application if he then finds that none of the grounds for denying ...
... application under subsection ( b ) , or such additional period as may be agreed upon by the Secretary and the applicant , the Secretary shall either- ( A ) approve the application if he then finds that none of the grounds for denying ...
Page 133
... application the patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of patent ...
... application the patent number and the expi- ration date of any patent which claims the drug for which the ap- plicant submitted the application or which claims a method of using such drug and with respect to which a claim of 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