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FDA Generic Biologics Short-Term Plan Includes Immunogenicity Document

Executive Summary

Immunogenicity and chemistry of follow-on biologics will be among the first issues FDA tackles in documents issued on the topic, Acting Commissioner Lester Crawford said at the Generic Pharmaceutical Association's annual meeting in Boca Raton, Fla

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FDA's Critical Path opportunities list suggests that the agency is actively working to lay the scientific groundwork for follow-on biologics

FDA Sees Critical Path Opportunity To Address Follow-On Biologics

FDA's Critical Path opportunities list suggests that the agency is actively working to lay the scientific groundwork for follow-on biologics

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