Pandemic Influenza Information
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.
General Information
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 - ARCHIVED
- Submission of an Investigational New Drug Application (IND) to CBER
- Development & Approval Process (CBER)