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2019-06-21
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Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing
Proposed Rules
D09002ee1c15eb3fc
D09002ee1c15eb499
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA, Agency, we) is holding a public hearing on September 17, 2019, entitled ``Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.'' The Agency today is issuing a draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs. This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.
84 FR 29112
https://www.govinfo.gov/app/details/FR-2019-06-21/2019-13219
2019-13219
fr21jn19-35
4164-01-P
Docket No. FDA-2019-N-2514
https://www.govinfo.gov/app/details/FR-2019-06-21/2019-13219
https://www.govinfo.gov/content/pkg/FR-2019-06-21/html/2019-13219.htm
https://www.govinfo.gov/content/pkg/FR-2019-06-21/pdf/2019-13219.pdf
3 p.
29112
29114
84 FR 29112
Code of Federal Regulations
Title 21 Part 15
21 CFR Part 15
Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics To Treat Pain and Addiction; Public Hearing; Federal Register Vol. 84, Issue
PRORULE
2019-13219
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-11-18
Docket No. FDA-2019-N-2514
4164-01-P
2019-13219
Notification of public hearing; request for comments.
The Food and Drug Administration (FDA, Agency, we) is holding a public hearing on September 17, 2019, entitled ``Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction.'' The Agency today is issuing a draft guidance on the application of FDA's existing benefit-risk assessment framework to applications for approval of opioid analgesic drugs. This public hearing is intended to receive stakeholder input on the approval process for new opioids and how FDA might best consider the existing armamentarium of therapies, among other factors, in reviewing applications for new opioids to treat pain. FDA also seeks input on potential new preapproval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.
The public hearing will be held on September 17, 2019, from 9 a.m. to 5 p.m. The public hearing may be extended or may end early depending on the level of public participation. Persons can attend the event in person or via webcast. In-person attendees can also request to give a formal presentation or to speak during the open public comment portion of the hearing. Section II provides attendance and registration information. Electronic or written comments will be accepted after the public hearing until November 18, 2019.
Nicole Zelenak, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6249, Silver Spring, MD 20993, 301-796- 9030; nicole.zelenak@fda.hhs.gov.
Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction
,
CDER-PublicMeeting@fda.hhs.gov
nicole.zelenak@fda.hhs.gov
https://www.eventbrite.com/e/fda-standards-for-future-opioid-therapy-approvals-part-15-meeting-tickets-60645674846
https://www.fda.gov
https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm
https://www.fda.gov/drugs/development-approval-process-drugs/standards-future-opioid-therapy-approvals-09172019-09172019
https://www.fda.gov/regulatoryinformation/dockets/default.htm
https://www.regulations.gov
Federal Register
Vol. 84, no. 120
Office of the Federal Register, National Archives and Records Administration
2019-06-21
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352 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2019-06-21
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https://www.govinfo.gov/app/details/FR-2019-06-21
https://www.govinfo.gov/content/pkg/FR-2019-06-21/pdf/FR-2019-06-21.pdf
https://www.govinfo.gov/content/pkg/FR-2019-06-21/xml/FR-2019-06-21.xml
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2019-06-21
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FR-2019-06-21
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