Smallpox

FDA grants fast track designation for smallpox vaccine candidate IMVAMUNE

Published in Medical Letter on the CDC and FDA, August 22nd, 2004

Bavarian Nordic has received fast track designation by the U.S. Food and Drug Administration (FDA) for its investigational new drug application covering the company's third-generation smallpox vaccine candidate IMVAMUNE (MVA-BN).

IMVAMUNE is the first and only smallpox vaccine candidate to receive this designation, according to the company.

The fast track designation gives priority review status to a license application and allows filing portions of license applications ahead of others. It facilitates frequent and ongoing communication with the FDA and is intended to facilitate development and expedite the review of new therapies that are intended to...

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Source: Medical Letter on the CDC and FDA (2004-08-22)

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