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
Hauptverfasser: Pines, Wayne L., Cotton, Mary Ann N.
Format: Artikel
Sprache:eng
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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.
ISSN:2168-4790
0092-8615
2168-4804
2164-9200
DOI:10.1177/009286159703100106