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2017-12-22
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Request for Nominations of Members for the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting nominations of patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC will be an ongoing, collaborative forum coordinated through the Patient Affairs Staff, Office of Medical Products and Tobacco (OMPT), Office of the Commissioner, and will be hosted by CTTI. Through the PEC, the patient community and regulators will be able to discuss an array of topics regarding increasing meaningful patient engagement in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patients and patient advocates are partners in certain aspects of the medical product development and FDA review process.
82 FR 60749
https://www.govinfo.gov/app/details/FR-2017-12-22/2017-27538
2017-27538
fr22de17-48
4164-01-P
Docket No. FDA-2017-N-6395
https://www.govinfo.gov/app/details/FR-2017-12-22/2017-27538
https://www.govinfo.gov/content/pkg/FR-2017-12-22/html/2017-27538.htm
https://www.govinfo.gov/content/pkg/FR-2017-12-22/pdf/2017-27538.pdf
2 p.
60749
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82 FR 60749
Request for Nominations of Members for the Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative; Federal Register Vol. 82, Issue
NOTICE
2017-27538
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2017-N-6395
4164-01-P
2017-27538
Notice.
The Food and Drug Administration (FDA or Agency), in collaboration with the Clinical Trials Transformation Initiative (CTTI), is requesting nominations of patient advocates interested in participating on the Patient Engagement Collaborative (PEC). The PEC will be an ongoing, collaborative forum coordinated through the Patient Affairs Staff, Office of Medical Products and Tobacco (OMPT), Office of the Commissioner, and will be hosted by CTTI. Through the PEC, the patient community and regulators will be able to discuss an array of topics regarding increasing meaningful patient engagement in medical product development and regulatory discussions at FDA. The activities of the PEC may include, but are not limited to, providing diverse perspectives on topics such as systematic patient engagement, transparency, and communication; providing considerations for implementing new strategies to enhance patient engagement at FDA; and proposing new models of collaboration in which patients and patient advocates are partners in certain aspects of the medical product development and FDA review process.
Nominations received by 11:59 p.m. Eastern Time on or before January 29, 2018, will be given first consideration for membership on the PEC. Nominations received after the submission deadline will be retained for future consideration.
Andrea Furia-Helms, Office of Medical Products and Tobacco, Office of the Commissioner, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 1316, Silver Spring, MD 20993, 301-796-8455, PatientEngagementCollaborative@fda.hhs.gov.
Requests for Nominations:
Clinical Trials Transformation Initiative/Food and Drug Administration Patient Engagement Collaborative
,
PatientEngagementCollaborative@fda.hhs.gov
https://www.ctti-clinicaltrials.org/framework-cttifda-patient-engagement-collaborative
Federal Register
Vol. 82, no. 245
Office of the Federal Register, National Archives and Records Administration
2017-12-22
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https://www.govinfo.gov/app/details/FR-2017-12-22
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https://www.govinfo.gov/app/details/FR-2017-12-22
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https://www.govinfo.gov/content/pkg/FR-2017-12-22/xml/FR-2017-12-22.xml
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