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FDA Issues Final Guidance To Boost Development Of Cell-Based Viral Vaccines PDF Print E-mail
Medical News - General Medical News - end 2009
The U.S. Food and Drug Administration issued final guidance to help manufacturers who are developing safe and effective cell-based viral vaccines to address emerging and pandemic threats. Titled "Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications," the document will aid manufacturers who wish to use new cell substrates for vaccine production, such as for influenza vaccines. Currently, all licensed influenza vaccines are produced in chicken eggs...


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