This study is
approved consistent with the revised supporting statement
(10/18/05). The study design is appropriate for the purpose of the
study identified in the supporting statement. However, in
describing the qualitative information collected, FDA will clearly
acknowledge that the results are not representative of the
industry's attitudes, knowledge, etc.
Inventory as of this Action
New legislation (MDUFMA 2) is being
contemplated to reauthorize the user fee program before it sunsets
in 2007. FDA would like to understand industry's perspective on
what worked and what did not work in MDUFMA, as well as what
changes industry would like to see if MDUFMA is reauthorized. FDA
is using a third party contractor to conduct an analysis of
industry members on this topic. A third party is being used to
obtain unbiased analyses and conclusions.