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2019-03-01
article
Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities; Public Meeting; Request for Comments
Notices
D09002ee1bdb7a90e
D09002ee1bdb7a9ac
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or the Agency) is announcing a public meeting and an opportunity for public comment on ``Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.'' This public meeting is intended to obtain patients' and caregivers' perspectives on impacts of rare diseases on daily life and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases. Developing a treatment for a rare disease can present unique challenges, such as the small number of individuals affected and heterogenous etiologies and manifestations. While the differences between rare diseases are critically important, it is also important to assess commonalities to synergize product development in rare diseases. The goal of this meeting is to identify common issues and symptoms in rare diseases to help advance medical product development, potentially through the creation of novel endpoints or trial designs that focus on commonalities across a variety of rare diseases.
84 FR 7082
https://www.govinfo.gov/app/details/FR-2019-03-01/2019-03675
2019-03675
fr01mr19-63
4164-01-P
Docket No. FDA-2019-N-0077
https://www.govinfo.gov/app/details/FR-2019-03-01/2019-03675
https://www.govinfo.gov/content/pkg/FR-2019-03-01/html/2019-03675.htm
https://www.govinfo.gov/content/pkg/FR-2019-03-01/pdf/2019-03675.pdf
3 p.
7082
7084
84 FR 7082
Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities; Public Meeting; Request for Comments; Federal Register Vol. 84, Issue
NOTICE
2019-03675
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-04-29
Docket No. FDA-2019-N-0077
4164-01-P
2019-03675
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA or the Agency) is announcing a public meeting and an opportunity for public comment on ``Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.'' This public meeting is intended to obtain patients' and caregivers' perspectives on impacts of rare diseases on daily life and to assess commonalities that may help the Agency and medical product developers further understand and advance the development of treatments for rare diseases. Developing a treatment for a rare disease can present unique challenges, such as the small number of individuals affected and heterogenous etiologies and manifestations. While the differences between rare diseases are critically important, it is also important to assess commonalities to synergize product development in rare diseases. The goal of this meeting is to identify common issues and symptoms in rare diseases to help advance medical product development, potentially through the creation of novel endpoints or trial designs that focus on commonalities across a variety of rare diseases.
The public meeting will be held on April 29, 2019, from 1 p.m. to 5 p.m. The online registration to attend must be received by April 15, 2019. Onsite registration on the day of the meeting will be based on space availability. Submit either electronic or written comments on the public meeting by May 30, 2019. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Eleanor Dixon-Terry, Office of Orphan Products Development, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5163, Silver Spring, MD 20933, 301-796-7634, OOPDOrphanEvents@fda.hhs.gov.
Meetings:
Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities
,
OOPDOrphanEvents@fda.hhs.gov
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
https://patient-perspectives-rare-diseases.eventbrite.com
https://www.adobe.com/go/connectpro_overview
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
https://www.fda.gov/NewsEvents/MeetingsConferencesWorkshops/ucm628352.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 41
Office of the Federal Register, National Archives and Records Administration
2019-03-01
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Table of Contents:
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AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-03-01
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2019-03-01
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FR-2019-03-01
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FR-2019-03-01
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