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U.S. Department of Health and Human Services

Drugs

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Public Hearing on the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907

FDA wants to hear from you about how women, minorities, and the elderly are included and evaluated in ClinicalTrials

The 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 FDA‐regulated medical products.

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

DateApril 1, 2014
Time9:00 a.m. to 4:00 p.m.
 
Location:FDA White Oak Campus
10903 New Hampshire Ave.
Building 31, Great Room  (1503)
Silver Spring, MD 20993
 

For more information and to register:

Visit the website at: FDA Public Hearing: FDASIA Section 907 
(Note: Registration for presenters closes on March 21, 2014)