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2019-02-01
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Risk Evaluation and Mitigation Strategies Assessment: Planning and Reporting; Draft Guidance for Industry; Availability
Notices
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D09002ee1bdb7c408
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the assessment of risk evaluation and mitigation strategies (REMS) entitled ``REMS Assessment: Planning and Reporting; Draft Guidance for Industry.'' The draft guidance is one of several guidance documents being developed to fulfill performance goals under the fifth authorization of the prescription drug user fee program, the Prescription Drug User Fee Act V. This draft guidance describes how to develop a REMS Assessment Plan; specifically, how the REMS program goals, objectives, and REMS design may impact the selection of metrics and data sources, which will be used to assess whether the REMS is meeting its risk mitigation goals. The draft guidance recommends assessing the REMS using both process measures and outcome measures and provides examples of metrics by assessment categories, as well as data sources that may be utilized to evaluate the performance of the REMS. The draft guidance also discusses considerations for assessing the impact of REMS on patient access to the drug or its burden to the healthcare delivery system. Finally, this draft guidance provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report.
84 FR 1153
https://www.govinfo.gov/app/details/FR-2019-02-01/2019-00676
2019-00676
fr01fe19-92
4164-01-P
Docket No. FDA-2018-D-4628
https://www.govinfo.gov/app/details/FR-2019-02-01/2019-00676
https://www.govinfo.gov/content/pkg/FR-2019-02-01/html/2019-00676.htm
https://www.govinfo.gov/content/pkg/FR-2019-02-01/pdf/2019-00676.pdf
3 p.
1153
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84 FR 1153
Risk Evaluation and Mitigation Strategies Assessment: Planning and Reporting; Draft Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-00676
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-04-02
Docket No. FDA-2018-D-4628
4164-01-P
2019-00676
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry on the assessment of risk evaluation and mitigation strategies (REMS) entitled ``REMS Assessment: Planning and Reporting; Draft Guidance for Industry.'' The draft guidance is one of several guidance documents being developed to fulfill performance goals under the fifth authorization of the prescription drug user fee program, the Prescription Drug User Fee Act V. This draft guidance describes how to develop a REMS Assessment Plan; specifically, how the REMS program goals, objectives, and REMS design may impact the selection of metrics and data sources, which will be used to assess whether the REMS is meeting its risk mitigation goals. The draft guidance recommends assessing the REMS using both process measures and outcome measures and provides examples of metrics by assessment categories, as well as data sources that may be utilized to evaluate the performance of the REMS. The draft guidance also discusses considerations for assessing the impact of REMS on patient access to the drug or its burden to the healthcare delivery system. Finally, this draft guidance provides recommendations on a standardized approach for reporting REMS assessment findings to FDA using the REMS Assessment Report.
Submit either electronic or written comments on the draft guidance by April 2, 2019 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Doris Auth, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2480, Silver Spring, MD 20993-0002, 301-796-0487, Doris.Auth@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911.
Guidance:
Risk Evaluation and Mitigation Strategies Assessment: Planning and Reporting
,
Doris.Auth@fda.hhs.gov
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM441226.pdf
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM521504.pdf
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm18&4128.pdf
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 22
Office of the Federal Register, National Archives and Records Administration
2019-02-01
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2019-02-01
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https://www.govinfo.gov/content/pkg/FR-2019-02-01/xml/FR-2019-02-01.xml
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