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
Schlagworte:	Advisory committees Biological and medical sciences Medical sciences Pharmaceutical industries Public health. Hygiene Public health. Hygiene-occupational medicine Regulatory agencies
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description	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.
doi_str_mv	10.1177/009286159703100106
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source	SAGE Complete A-Z List; Springer Nature - Complete Springer Journals
subjects	Advisory committees Biological and medical sciences Medical sciences Pharmaceutical industries Public health. Hygiene Public health. Hygiene-occupational medicine Regulatory agencies
title	Preparing for an FDA Advisory Committee Meeting
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