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Drug Information Update - FDA is announcing a public hearing to obtain input on the issues and challenges associated with the collection, analysis, and availability of demographic subgroup data in applications for approval of FDA-regulated human medical products

FDA Division of Drug Information: Know the Moment It Happens

The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.


Food and Drug Administration (FDA) is announcing 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 FDAregulated medical products.  The public hearing will take place April 1, 2014 from 9:00 a.m. to 3:00 p.m.

The Agency will utilize input from this public hearing to develop a plan that is pragmatic and publichealth focused.

There will be an opportunity for attendees to make oral presentations during the meeting. The deadline for registering as a presenter is March 21, 2014. There is also an open public docket for the meeting. Comments will be accepted until May 16, 2014.

For more information, please visit: Public Hearing and Comment Request


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