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Record Nr. |
UNINA9910699281003321 |
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Titolo |
Guidance for industry [[electronic resource] ] : listed drugs, 30 month stays, and approval of ANDAs and 505(b)(2) applications under Hatch-Waxman, as amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, questions and answers |
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Pubbl/distr/stampa |
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Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2004] |
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Descrizione fisica |
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1 online resource (12 pages) |
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Soggetti |
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Drug approval - United States |
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Lingua di pubblicazione |
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Formato |
Materiale a stampa |
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Livello bibliografico |
Monografia |
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Note generali |
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"Draft guidance." |
"OGD." |
"October 2004." |
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