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2015-10-06
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Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project
Notices
D09002ee1c18505a8
D09002ee1c1850618
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 pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Participation in the pilot is voluntary and is open to application holders of drugs with REMS. The pilot is intended to help application holders, FDA, and other interested stakeholders evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. This project also will help provide FDA with feedback on these topics from pilot participants and other interested stakeholders.
80 FR 60391
https://www.govinfo.gov/app/details/FR-2015-10-06/2015-25349
2015-25349
fr06oc15-63
4164-01-P
Docket No. FDA-2015-N-3402
https://www.govinfo.gov/app/details/FR-2015-10-06/2015-25349
https://www.govinfo.gov/content/pkg/FR-2015-10-06/html/2015-25349.htm
https://www.govinfo.gov/content/pkg/FR-2015-10-06/pdf/2015-25349.pdf
3 p.
60391
60393
80 FR 60391
Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project; Federal Register Vol. 80, Issue
NOTICE
2015-25349
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2015-10-06
Docket No. FDA-2015-N-3402
4164-01-P
2015-25349
Notice of pilot project, request for comments.
The Food and Drug Administration (FDA or Agency) is announcing a pilot project for the submission of final approved Risk Evaluation and Mitigation Strategies (REMS) and certain REMS summary information electronically in a standard Structured Product Labeling (SPL) format. Participation in the pilot is voluntary and is open to application holders of drugs with REMS. The pilot is intended to help application holders, FDA, and other interested stakeholders evaluate a potential approach to converting REMS into SPL format and evaluate the usefulness of the REMS information to be provided in SPL format. This project also will help provide FDA with feedback on these topics from pilot participants and other interested stakeholders.
Submit requests to participate in the REMS SPL pilot from October 6, 2015 to December 7, 2015. See the ``Participation'' section for instructions on how to submit a request to participate. The pilot will proceed for 4 months, from October 6, 2015 to February 3, 2016. This pilot may be extended as resources and needs allow.
Adam Kroetsch at REMS_Standardization@fda.hhs.gov or at 301-796-3842.
Electronic Submission of Final Approved Risk Evaluation and Mitigation Strategies and Summary Information in a Standard Structured Product Labeling Format; Pilot Project
,
REMS_Standardization@fda.hhs.gov
http://www.fda.gov/downloads/Drugs/.../Guidances/UCM184128.pdf
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM362078.pdf
http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM415751.pdf
http://www.fda.gov/esg/default.htm
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/ucm189651.htm
http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.fda.gov/REMS
http://www.regulations.gov
Federal Register
Vol. 80, no. 193
Office of the Federal Register, National Archives and Records Administration
2015-10-06
continuing
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244 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2015-10-06
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https://www.govinfo.gov/app/details/FR-2015-10-06
https://www.govinfo.gov/content/pkg/FR-2015-10-06/pdf/FR-2015-10-06.pdf
https://www.govinfo.gov/content/pkg/FR-2015-10-06/xml/FR-2015-10-06.xml
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