FDA Finalizes Guidances For Pandemic And Seasonal Influenza Vaccines
The U.S. Food and Drug Administration 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.
"FDA continues its commitment to help increase the supply of influenza vaccines and support the development of new approaches to vaccine production," said Jesse L. Goodman, M.D., M.P.H., director of FDA's Center for Biologics Evaluation and Research (CBER). "Having additional manufacturers of licensed influenza vaccines will enhance the capacity to produce more doses of seasonal influenza vaccines, as well as contribute to the nation's pandemic preparedness, one of our top priorities."
In March 2006, FDA issued two draft guidance documents for public comment