This public meeting will present FDA’s progress in implementing the “Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data,” required under Sec. 907 of the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA will also be seeking feedback and recommendations from stakeholder groups: patient groups, consumer groups, regulated industry, academia and other interested parties are welcome.
DATE:
Monday February 29, 2016 from 9:00 a.m. to 4:00 p.m.
LOCATION:
FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (B C), Silver Spring, MD 20993-0002.
BACKGROUND:
For more background information about Sec.907 of the Food and Drug Administration Safety and Innovation Act (FDASIA) please visit our website at:
http://www.fda.gov/RegulatoryInformation/Legislation/SignificantAmendmentstotheFDCAct/FDASIA/ucm389100.htm
REGISTRATION:
If you wish to attend this meeting, please register by close of business on February 13, 2016. There is no fee to register for the meeting and registration will be on a first-come, first-served basis. Early registration is recommended because seating is limited.
An email confirmation will be sent to those who register and FDA will post the full agenda and Information on how to access the Webcast approximately 5 days before the meeting.
If you require special accommodations due to a disability, or need additional information regarding registration, please email FDASIA907.
There will be a public session during the meeting. All those requesting to speak should register by emailing FDASIA907 by February 1, 2016.
DISCUSSION:
Some questions we would like the public to comment on during the meeting include:
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What approaches have been successful in addressing key barriers to recruiting diverse clinical trial populations?
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What are your key limitations to conducting meaningful data analysis of underrepresented groups?
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What have you learned about best practices for recruiting a broad representation of subjects for clinical trials? Which practices have been successful and why? Which have not and why?
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What communication strategies have you successfully used that were also sensitive to the needs of underrepresented populations?
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What are potential methods can FDA should consider using to effectively communicate meaningful information on demographic analyses to a diverse public?
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What are some of the actual or potential unintended consequences of data transparency you have encountered related to reporting demographic subgroup analysis?
Stakeholders are invited to provide brief comments on these topics during the public comment portion of the meeting but are not limited to discussing the above topics alone. Since the day-long meeting may not provide enough time to fully address all of these issues, we encourage interested groups to submit longer explanations and comments to the docket.
INCLEMENT WEATHER:
We will be holding the workshop as planned if the FDA White Oak campus is open. The operating status of the campus facilities is available at http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/ucm229281.htm
If a public announcement is made that federal government offices are closed, the workshop will not be held and will be rescheduled.
CONTACT US:
For questions regarding this meeting, please contact the FDASIA907 Steering Committee.