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Negocios · 14/10/20101 min de lectura
Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability
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Resumen
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Early Clinical Trials with Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information" dated September 2010. The draft guidance provides investigational new drug application (IND) sponsors with recommendations on the submission of INDs for early clinical trials with live biotherapeutic products (LBPs).
Idioma original de la fuente: Federal Register — Health and Human ServicesAbrir el comunicado original →