PUBLIC MEETING: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data

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Good afternoon,

The FDA Office of Minority Health (OMH) invites you to attend the Food and Drug Administration Safety and Innovation Act (FDASIA) Public Meeting: Progress on Enhancing the Collection, Analysis, and Availability of Demographic Subgroup Data.

Date:          February, 29, 2016

Time:          9 AM- 4 PM

Location:     FDA White Oak Campus
                  The Great Room
                  10903 New Hampshire Ave
                  Silver Spring, MD 20993

Register by February 13, 2016

The meeting will discuss the progress the agency has made since the 2014 release of the "Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data." The report was created in response to the president signing FDASIA into law in 2012. 

Section 907 of FDASIA directed FDA to publish and provide to Congress a report "addressing the extent to which clinical trial participation and the inclusion of safety and effectiveness data by demographic subgroups, including sex, age, race, and ethnicity, is included in applications submitted to FDA," among other requirements.

Specifically the plan aims to: 

(1) Improve quality and quantity of data derived from under-represented groups in clinical trials; 

(2) Increase the participation in clinical trials; and 

(3) Make data from clinical trials publicly available.

Learn more about FDASIA 907

Clinical Trials Shed Light on Minority Health

FDA seeks comments that (1) discuss how stakeholders have been affected by the changes implemented in the Action Plan, and (2) make recommendations for improvement. 

Comment to the Docket by February 1, 2016.

To make an oral presentation at the meeting, send a brief summary of your comments and registration information (name, title, firm name, address, telephone number, email address, and fax number) toFDASIA907@FDA.HHS.gov by February 1, 2016.

It is very important to ensure that diverse perspectives are represented. We want to encourage you to make your voice heard by submitting comments on this important topic.

Best Regards,

Dr. Jonca Bull
Assistant Commissioner for Minority Health