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Guidance on Licensure of Pandemic Influenza Vaccines

06/01/2007

Federal Register Notice: FDA is making available Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines. The document provides information on clinical development approaches to facilitate and expedite the licensure (a traditional BLA or a BLA using the accelerated approval pathway) of influenza vaccines for preventing disease caused by pandemic influenza viruses. To download this guidance, click here. To view this notice, click here.

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