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IPQ Inside the global regulatory dialogue

FDA’s BLA Review Sheds Light on Evolution of Biotherapeutic Product Analytical Methods and Their Regulation

Nov 12th, 2018

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OBP’s Shapiro Reviews BLA Analytical Landscape At a plenary session of the WCBP conference on “Technical Innovations to Support Development and Global Regulatory Approval for Biological Products and Vaccines,” OBP Team Leader Marjorie Shapiro offered...

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