Pandemic influenza (flu) is a significant global public health threat. Preparedness has been recognized as a critical local, national and worldwide priority. CBER plays a critical role in fostering the development and increasing the availability of and access to safe and effective biological products to preserve public health by controlling this and other emerging infectious disease threats to public health.
Commenting to the Docket
Product Development and Approval
Influenza Virus Vaccine, H5N1 (for National Stockpile) H5N1 Influenza Virus Vaccine, manufactured by Sanofi Pasteur, Inc. Questions and Answers Vaccine Product Approval Process Information on Submitting an Investigational New Drug Application Guidance for Industry: Clinical Data Needed to Support the Licensure of Pandemic Influenza Vaccines Guidance for Industry: Clinical Data Needed to Support the Licensure of Seasonal Inactivated Influenza Vaccines Development & Approval Process (CBER) FDA Forms