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2018-02-07
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Public Meeting on Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant
Notices
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D09002ee1bdc1c3e3
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) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for patients who have received an organ transplant. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of receiving an organ transplant on daily life and patient views on treatment approaches; the input from this public meeting will help in developing topics for further discussion. FDA is also interested in discussing issues related to scientific challenges in developing drugs to manage organ transplantation. In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to manage organ transplantation.
81 FR 24818
https://www.govinfo.gov/app/details/FR-2016-04-27/2016-09785
2016-09785
fr27ap16-61
4164-01-P
Docket No. FDA-N-2016-1134
https://www.govinfo.gov/app/details/FR-2016-04-27/2016-09785
https://www.govinfo.gov/content/pkg/FR-2016-04-27/html/2016-09785.htm
https://www.govinfo.gov/content/pkg/FR-2016-04-27/pdf/2016-09785.pdf
3 p.
24818
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81 FR 24818
Public Meeting on Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant; Federal Register Vol. 81, Issue
NOTICE
2016-09785
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-11-27
2016-09-27
Docket No. FDA-N-2016-1134
4164-01-P
2016-09785
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient- Focused Drug Development for patients who have received an organ transplant. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of receiving an organ transplant on daily life and patient views on treatment approaches; the input from this public meeting will help in developing topics for further discussion. FDA is also interested in discussing issues related to scientific challenges in developing drugs to manage organ transplantation. In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients and patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended to manage organ transplantation.
The public meeting will be held on September 27, 2016, from 9 a.m. to 5 p.m. Please register here for the meeting by September 20, 2016: http://organtransplantpfdd.eventbrite.com. Submit electronic or written comments to the public docket by November 27, 2016.
Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796- 5003, FAX: 301-847-8443, graham.thompson@fda.hhs.gov.
Meetings:
Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant
,
graham.thompson@fda.hhs.gov
PatientFocused@fda.hhs.gov
http://organtransplantpfdd.eventbrite.com
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm495933.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 81
Office of the Federal Register, National Archives and Records Administration
2016-04-27
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Table of Contents:
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GS 4.107:
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https://www.govinfo.gov/app/details/FR-2016-04-27
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https://www.govinfo.gov/app/details/FR-2016-04-27
https://www.govinfo.gov/content/pkg/FR-2016-04-27/pdf/FR-2016-04-27.pdf
https://www.govinfo.gov/content/pkg/FR-2016-04-27/xml/FR-2016-04-27.xml
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