FDA Finalizes Guidances for Pandemic and Seasonal Influenza Vaccines

by Sabrina I. Pacifici on June 3, 2007

Press release, May 31, 2007: “The U.S. Food and Drug Administration (FDA) today issued final recommendations to increase the supply of safe and effective influenza vaccines for both seasonal and pandemic use. FDA’s goal with the guidances is to outline the regulatory pathways for the rapid development and approval of these products.”

  • Guidance for Industry, Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines
  • Guidance for Industry, Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines
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