Pandemic Influenza
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.
PandemicFlu.gov - One-stop access to U.S. Government avian and pandemic flu information
Approved Influenza Virus Vaccines
Product Development and Approval
- Influenza Virus Vaccine, H5N1
- H5N1 Influenza Virus Vaccine Questions and Answers
- Vaccine Product Approval Process
- Information on Submitting an Investigational New Drug Application for a Biological Product
- 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
- Regulatory Submissions in Electronic Format
- FDA Forms (Biologics)
- Public Health Service Act - Licensing of Biological Products - US Code, Title 42, Chapter 6A, Subpart II, Part F, Subpart 1, Sec. 262 and 263
Meeting Presentations
- Accelerating the Development & Availability of Vaccines for a Pandemic or Other Emerging Threats: Present and Future (2006 FDA Science Forum) - Jesse Goodman, MD, MPH
- How fast can a new vaccine for an emerging respiratory virus be developed and available for use? - Jesse L. Goodman, MD, MPH
- Immune Correlates of Protection Against Influenza A Viruses in Support of Pandemic Vaccine Development
Publications and News Releases
- Influenza: Vaccination Still the Best Protection (September-October 2006 FDA Consumer Magazine)
- FDA Names First Medical Director for Emerging and Pandemic Threat Preparedness in the Center for Biologics Evaluation and Research
- FDA Approves New Laboratory Test To Detect Human Infections With Avian Influenza A/H5 Viruses
- FDA Announces Rapid Response Team to Combat Pandemic (Avian) Flu
- HHS Unveils Two New Efforts to Advance Pandemic Flu Preparedness
- Pandemic or Avian Flu -- What's the Difference?