Preparing for an FDA Advisory Committee Meeting
Company presentations to Food and Drug Administration (FDA) advisory committees are critically important in securing product approval. This paper presents the history and present status of FDA advisory committees. It then details a systematic approach to advisory committee preparation, including 10...
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Veröffentlicht in: | Drug information journal 1997, Vol.31 (1), p.35-41 |
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Hauptverfasser: | , |
Format: | Artikel |
Sprache: | eng |
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Online-Zugang: | Volltext |
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Zusammenfassung: | Company presentations to Food and Drug Administration (FDA) advisory committees are critically important in securing product approval. This paper presents the history and present status of FDA advisory committees. It then details a systematic approach to advisory committee preparation, including 10 fundamental steps. |
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ISSN: | 2168-4790 0092-8615 2168-4804 2164-9200 |
DOI: | 10.1177/009286159703100106 |