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Negócios · 14/10/20101 min de leitura
Draft Guidance for Industry: Early Clinical Trials With Live Biotherapeutic Products: Chemistry, Manufacturing, and Control Information; Availability
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Resumo
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 The draft guidance provides investigational new drug application (IND) sponsors with recommendations on the submission of INDs for early clinical trials with live biotherapeutic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 da fonte: Federal Register — Health and Human ServicesAbrir o comunicado original →