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Accelerated Approval Gives Wings To Pandemic Flu Vaccine Development

Executive Summary

FDA has unveiled a strategy for preventing influenza vaccine shortages and getting a jump on flu pandemics by using surrogate endpoints to accelerate approval of new vaccines

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Final FDA flu vaccine guidances

FDA issues final guidances to outline the regulatory pathways for development and approval of seasonal and pandemic influenza vaccines May 31. Both guidances recommend use of novel adjuvants and cell culture and recombinant manufacturing technologies. Guidelines also allow use of surrogate endpoints such as immune response to support accelerated approval (1"The Pink Sheet" March 13, 2006, p. 26)...

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