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2018-10-25
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Format and Content of a Risk Evaluation and Mitigation Strategy Document; Revised Draft Guidance for Industry; Availability
Notices
D09002ee1bdbabf95
D09002ee1bdbac033
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Format and Content of a REMS Document.'' A Risk Evaluation and Mitigation Strategy (REMS) document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS. This revised draft guidance describes a new recommended format for a REMS document. The new format was developed based on extensive stakeholder feedback. This guidance revises and supersedes the draft guidance entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,'' that was published by FDA on October 1, 2009.
82 FR 47529
https://www.govinfo.gov/app/details/FR-2017-10-12/2017-22050
2017-22050
fr12oc17-75
4164-01-P
Docket No. FDA-2009-D-0461
https://www.govinfo.gov/app/details/FR-2017-10-12/2017-22050
https://www.govinfo.gov/content/pkg/FR-2017-10-12/html/2017-22050.htm
https://www.govinfo.gov/content/pkg/FR-2017-10-12/pdf/2017-22050.pdf
3 p.
47529
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82 FR 47529
Format and Content of a Risk Evaluation and Mitigation Strategy Document; Revised Draft Guidance for Industry; Availability; Federal Register Vol. 82, Issue
NOTICE
2017-22050
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2017-12-11
Docket No. FDA-2009-D-0461
4164-01-P
2017-22050
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled ``Format and Content of a REMS Document.'' A Risk Evaluation and Mitigation Strategy (REMS) document, which is part of a REMS that is required by FDA, establishes the goals and requirements of the REMS. This revised draft guidance describes a new recommended format for a REMS document. The new format was developed based on extensive stakeholder feedback. This guidance revises and supersedes the draft guidance entitled ``Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications,'' that was published by FDA on October 1, 2009.
Submit either electronic or written comments on the draft guidance by December 11, 2017 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.
Gita Toyserkani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2422, Silver Spring, MD 20993, 301-796- 1783, Gita.Toyserkani@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:
Format and Content of a Risk Evaluation and Mitigation Strategy Document
,
Gita.Toyserkani@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/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm350852.htm
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm521504.pdf
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 82, no. 196
Office of the Federal Register, National Archives and Records Administration
2017-10-12
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257 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2017-10-12
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https://www.govinfo.gov/app/details/FR-2017-10-12
https://www.govinfo.gov/content/pkg/FR-2017-10-12/pdf/FR-2017-10-12.pdf
https://www.govinfo.gov/content/pkg/FR-2017-10-12/xml/FR-2017-10-12.xml
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2018-10-25
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