On February 7, 2014, FDA conducted a public meeting on Patient-Focused Drug Development for sickle cell disease. FDA is interested in obtaining patients’ perspectives on the impact of sickle cell disease on daily life as well as the available therapies for sickle cell disease.
|Date:||February 7, 2014|
|Time:||10 a.m. to 4 p.m.|
|Location:||FDA White Oak Campus|
10903 New Hampshire Ave.
Building 31, Room 1503 B and C (Great Room)
Silver Spring, MD 20993
(Information about arrival to FDA's White Oak campus)
|Registration:||To register for this meeting, visit: Registration information.|
Registration has been extended and will close on February 3, 2014.
Submitting comments to the docket: In addition to providing input at the public meeting, patient stakeholders are invited to provide their perspectives on the discussion questions through the public docket. The docket closes on April 8, 2014.
- FDA is interested in patient responses to the questions listed in the Federal Register Notice.
- Visit the following website to submit your comment: Notice of public meeting; request for comments.
- Alternatively, you can submit comments through fax or mail. Fax comments to the Division of Dockets Management at 301-827-6870, or mail comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should include the docket number FDA-2013-N-1328.
- Part 1 - https://collaboration.fda.gov/p6q3sa7ylei/
- Part 2 - https://collaboration.fda.gov/p3fcverdb3o/
- Meeting Agenda (PDF - 116KB)
- Sickle Cell Disease Public Meeting on Patient-Focused Drug Development
Federal Register Notice (11/6/2013)
Flyer for Sickle Cell Disease Meeting(PDF - 239KB) Webinar: Background on FDA and Patient-Focused Drug Development
- Meeting Slides (PDF - 513KB)
Transcript: Sickle Cell Disease Meeting(PDF - 1.3MB)
- FDA’s Consumer Update article on Sickle Cell Disease
(posted October 14, 2014)
Patient-Focused Drug Development: Disease Area Meetings Planned for Fiscal Years 2013-2017 Enhancing Benefit-Risk Assessment in Regulatory Decision-Making FDA Helps Tackle Sickle Cell Disease Helping to develop new treatments is an agency priority.