US FDA guidance to expedite flu vaccs

The US Food and Drug Administration issued recommendations to aid manufacturers in developing seasonal and pandemic influenza vaccines. The FDA's goal is to expedite the development and availability of safe and effective vaccines needed to protect against influenza.

"This action illustrates FDA's high level of commitment and key role in preparing for influenza pandemic, which is a top priority for our nation" said Acting FDA Commissioner Andrew von Eschenbach.

In two guidance documents released this month, one for seasonal and the other for pandemic influenza vaccines, the FDA provides manufacturers with clear advice on developing and submitting clinical data to show safety and effectiveness for new vaccines. Consistent with the aims of the FDA's Critical Path Initiative to get products to market more quickly and to advance the development and use of new technologies, these documents outline specific approaches that vaccine developers may follow.