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2019-11-14
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Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision Making; Public Workshop; Request for Comments
Notices
D09002ee1bdb6aa33
D09002ee1bdb6aa98
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, the Agency, or we) is announcing a public workshop to convene a discussion on incorporating clinical outcome assessments (COAs) into endpoints for regulatory decision making. This workshop will inform development of patient- focused drug development guidance as required by the 21st Century Cures Act (Cures Act) and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Amendments (PDUFA VI). The Agency will publish a discussion document approximately 1 month before the workshop date. FDA is interested in seeking information and comments on the approaches proposed in the discussion document, as well as input on examples that could be illustrated in the forthcoming draft guidance, where approaches proposed in the discussion document have been successfully applied.
84 FR 61912
https://www.govinfo.gov/app/details/FR-2019-11-14/2019-24726
2019-24726
FR14NO19-49
4164-01-P
Docket No. FDA-2019-N-4900
https://www.govinfo.gov/app/details/FR-2019-11-14/2019-24726
https://www.govinfo.gov/content/pkg/FR-2019-11-14/html/2019-24726.htm
https://www.govinfo.gov/content/pkg/FR-2019-11-14/pdf/2019-24726.pdf
2 p.
61912
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84 FR 61912
Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments Into Endpoints for Regulatory Decision Making; Public Workshop; Request for Comments; Federal Register Vol. 84, Issue
NOTICE
2019-24726
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-02-04
Docket No. FDA-2019-N-4900
4164-01-P
2019-24726
Notice of public workshop; request for comments.
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public workshop to convene a discussion on incorporating clinical outcome assessments (COAs) into endpoints for regulatory decision making. This workshop will inform development of patient- focused drug development guidance as required by the 21st Century Cures Act (Cures Act) and as part of commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Amendments (PDUFA VI). The Agency will publish a discussion document approximately 1 month before the workshop date. FDA is interested in seeking information and comments on the approaches proposed in the discussion document, as well as input on examples that could be illustrated in the forthcoming draft guidance, where approaches proposed in the discussion document have been successfully applied.
The public workshop will be held on December 6, 2019, from 9 a.m. to 5 p.m. Submit either electronic or written comments on this public workshop by February 4, 2020. See the SUPPLEMENTARY INFORMATION section for registration date and information.
Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 240-402-6525, Fax: 301-847-8443, meghana.chalasani@fda.hhs.gov.
Meetings:
Patient-Focused Drug Development Guidance: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making; Public Workshop,
meghana.chalasani@fda.hhs.gov
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm
https://collaboration.fda.gov/pfddg123119/
https://patientfocuseddrugdevelopment.eventbrite.com
https://www.adobe.com/go/connectpro_overview
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
https://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM511438.pdf
https://www.fda.gov/drugs/news-events-human-drugs/patient-focused-drug-development-guidance-collection-and-analysis-clinical-outcome-assessment-data
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 220
Office of the Federal Register, National Archives and Records Administration
2019-11-14
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2019-11-14
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https://www.govinfo.gov/app/details/FR-2019-11-14
https://www.govinfo.gov/content/pkg/FR-2019-11-14/pdf/FR-2019-11-14.pdf
https://www.govinfo.gov/content/pkg/FR-2019-11-14/xml/FR-2019-11-14.xml
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