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
... drug product , ( B ) production , quality assurance , or quality control of any drug product , or ( C ) research and development of any drug product . ( dd ) For purposes of sections 306 and 307 , the term " drug prod- uct " means a ...
... drug product , ( B ) production , quality assurance , or quality control of any drug product , or ( C ) research and development of any drug product . ( dd ) For purposes of sections 306 and 307 , the term " drug prod- uct " means a ...
Page 27
... DRUG APPLICATIONS.- ( 1 ) CORPORATIONS , PARTNERSHIPS , AND ASSOCIATIONS . — If the Secretary finds that a person ... product under this Act , the Secretary shall debar such individual from providing serv- ices 27 27 Sec . 306 FEDERAL FOOD , ...
... DRUG APPLICATIONS.- ( 1 ) CORPORATIONS , PARTNERSHIPS , AND ASSOCIATIONS . — If the Secretary finds that a person ... product under this Act , the Secretary shall debar such individual from providing serv- ices 27 27 Sec . 306 FEDERAL FOOD , ...
Page 28
... drug product application . ( b ) PERMISSIVE DEBARMENT ; CERTAIN DRUG APPLICATIONS ; FOOD IMPORTS.- ( 1 ) IN GENERAL . - The Secretary , on the Secretary's own initiative or in response to a petition , may , in accordance with paragraph ...
... drug product application . ( b ) PERMISSIVE DEBARMENT ; CERTAIN DRUG APPLICATIONS ; FOOD IMPORTS.- ( 1 ) IN GENERAL . - The Secretary , on the Secretary's own initiative or in response to a petition , may , in accordance with paragraph ...
Page 30
... drug product application and shall not accept or review ( other than in connection with an audit under this section ) an abbreviated drug application from such individual , and ( C ) shall , if the Secretary makes the finding described ...
... drug product application and shall not accept or review ( other than in connection with an audit under this section ) an abbreviated drug application from such individual , and ( C ) shall , if the Secretary makes the finding described ...
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such drug is in substantial compliance with the applicable requirements of ... product shall include ( 1 ) a certification that the applicant did not and ... drug application , a list of all convictions , described in subsections ( a ) ...
such drug is in substantial compliance with the applicable requirements of ... product shall include ( 1 ) a certification that the applicant did not and ... drug application , a list of all convictions , described in subsections ( a ) ...
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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