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2017-01-27
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Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy; Availability; Request for Comments
Notices
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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) is announcing the availability of a draft document entitled ``Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS'' (Blueprint). The draft Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended-release opioids under the required risk evaluation and mitigation strategy (REMS) for these products (Opioid REMS). FDA seeks stakeholder input on the document. After comments are received, FDA will revise the Blueprint as appropriate, incorporate it into the Opioid REMS when it is approved, and post it on FDA's Web site for use by CE providers.
76 FR 68766
https://www.govinfo.gov/app/details/FR-2011-11-07/2011-28669
2011-28669
fr07no11-62
4160-01-P
Docket No. FDA-2011-D-0771
https://www.govinfo.gov/app/details/FR-2011-11-07/2011-28669
https://www.govinfo.gov/content/pkg/FR-2011-11-07/html/2011-28669.htm
https://www.govinfo.gov/content/pkg/FR-2011-11-07/pdf/2011-28669.pdf
2 p.
68766
68767
76 FR 68766
Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy; Availability; Request for Comments; Federal Register Vol. 76, Issue
NOTICE
2011-28669
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2011-12-07
Docket No. FDA-2011-D-0771
4160-01-P
2011-28669
Notice; request for comments.
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Blueprint for Prescriber Education for the Long-Acting/Extended-Release Opioid Class-Wide REMS'' (Blueprint). The draft Blueprint contains core messages intended for use by continuing education (CE) providers to develop educational materials to train prescribers of long-acting and extended-release opioids under the required risk evaluation and mitigation strategy (REMS) for these products (Opioid REMS). FDA seeks stakeholder input on the document. After comments are received, FDA will revise the Blueprint as appropriate, incorporate it into the Opioid REMS when it is approved, and post it on FDA's Web site for use by CE providers.
Submit either electronic or written comments on the draft Blueprint by December 7, 2011.
Michie I. Hunt, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6153, Silver Spring, MD 20993-0002, (301) 796-3504.
Draft Blueprint for Prescriber Education; Availability:
Long-Acting/Extended-Release Opioid Class-Wide Risk Evaluation and Mitigation Strategy
,
http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM163652.pdf
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163654.htm
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258113.htm
http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258184.htm
http://www.regulations.gov
www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf
Federal Register
Vol. 76, no. 215
Office of the Federal Register, National Archives and Records Administration
2011-11-07
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462 p.
Table of Contents:
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GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2011-11-07
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https://www.govinfo.gov/app/details/FR-2011-11-07
https://www.govinfo.gov/content/pkg/FR-2011-11-07/pdf/FR-2011-11-07.pdf
https://www.govinfo.gov/content/pkg/FR-2011-11-07/xml/FR-2011-11-07.xml
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