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U.S. Department of Health and Human Services

Regulatory Information

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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

Meeting Information