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並前往https://www.ema.europa.eu/documents/presentation/presentation-activities-usa-experience-fda-neurology-division-russel-katz_en.pdf

Experience of the FDA Division of Neurology Products

The sponsor (Biogen Idec) submitted a Biologic License. Application for natalizumab in May 2004. • The development program consisted of 5 Phase 3 studies.

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