Public Hearing on FDASIA Section 907
The Food and Drug Administration held a public hearing to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data (i.e. sex, race/ethnicity, and age) in applications for approval of FDA‐regulated medical products.
The Agency will utilize input from this public hearing to develop a plan that is pragmatic and public‐health focused.
The open public docket for this meeting is now closed. You may review comments that were submitted here: Docket No. FDA-2013-N-0745
April 1, 2014
9 a.m. to 4 p.m.
FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Great Room
Silver Spring, MD 20993