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2019-02-07
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Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment; Guidance for Industry; Availability
Notices
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D09002ee1bdb7bf7c
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 final guidance for industry entitled ``Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.'' This guidance reflects the Agency's current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder. Passive- compliance formulations such as sustained-release injectable depots and implants can provide effective treatment of opioid use disorder in a treatment paradigm that may be less subject to misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films. This guidance finalizes the draft guidance entitled ``Opioid Dependence: Developing Depot Buprenorphine Products for Treatment'' issued in April 2018.
84 FR 2527
https://www.govinfo.gov/app/details/FR-2019-02-07/2019-01517
2019-01517
fr07fe19-66
4164-01-P
Docket No. FDA-2018-D-1334
https://www.govinfo.gov/app/details/FR-2019-02-07/2019-01517
https://www.govinfo.gov/content/pkg/FR-2019-02-07/html/2019-01517.htm
https://www.govinfo.gov/content/pkg/FR-2019-02-07/pdf/2019-01517.pdf
2 p.
2527
2528
84 FR 2527
Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment; Guidance for Industry; Availability; Federal Register Vol. 84, Issue
NOTICE
2019-01517
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2018-D-1334
4164-01-P
2019-01517
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment.'' This guidance reflects the Agency's current thinking regarding drug product development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation) for the treatment of opioid use disorder. Passive- compliance formulations such as sustained-release injectable depots and implants can provide effective treatment of opioid use disorder in a treatment paradigm that may be less subject to misuse, abuse, or accidental exposure compared to self-administered formulations such as transmucosal tablets and films. This guidance finalizes the draft guidance entitled ``Opioid Dependence: Developing Depot Buprenorphine Products for Treatment'' issued in April 2018.
The announcement of the guidance is published in the Federal Register on February 7, 2019.
Silvana Borges, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3200, Silver Spring, MD 20993-0002, 301- 796-0963.
Guidance:
Opioid Use Disorder: Developing Depot Buprenorphine Products for Treatment
,
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 84, no. 26
Office of the Federal Register, National Archives and Records Administration
2019-02-07
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288 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2019-02-07
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https://www.govinfo.gov/app/details/FR-2019-02-07
https://www.govinfo.gov/content/pkg/FR-2019-02-07/pdf/FR-2019-02-07.pdf
https://www.govinfo.gov/content/pkg/FR-2019-02-07/xml/FR-2019-02-07.xml
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