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FDA: final guidance on developing cell-based viral vaccines

This article was originally published in Scrip

Executive Summary

The US FDA recognises emerging and pandemic threats – and it aims to boost the development of cell-based viral vaccines with the publication of a final guidance entitled Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in Production of Viral Vaccines for Infectious Disease Indications. The Health and Human Services (HHS) Secretary announced the guidance's availability March 2nd.



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