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  4. Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing - 09/17/2019 - 09/17/2019
  1. Development & Approval Process | Drugs

Meeting | Mixed

Event Title
Standards for Future Opioid Analgesic Approvals and Incentives for New Therapeutics to Treat Pain and Addiction; Public Hearing
September 17, 2019

Date:
September 17, 2019

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 The Agency issued the draft guidance (see Opioid Analgesic Drugs: Considerations for Benefit Risk Assessment Framework) on the application of FDA’s existing benefit-risk assessment framework to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 pre-approval incentives aimed at fostering the development of new therapeutics to treat pain, as well as new treatments for addiction.

The meeting will be held from 9 a.m. to 4 p.m. at:

FDA White Oak Campus
10903 New Hampshire Avenue
Building 31 Conference Center, Great Room B/C
Silver Spring, MD 20993-0002

The entrance for public hearing participants (non-FDA employees or contractors) is through Building 1, where routine security check procedures will be performed. For parking, security and other visitor information, please refer to Public Meetings at the FDA White Oak Campus.

Meeting Information

Meeting Materials

Registration

Please use this Eventbrite Link to register for the event. Registration is first come first serve. The following are registration options for participation:

  • In-Person Attendee
  • In-Person Presenter (approximately 10-minute timed presentation, with optional slide deck, followed by a 2-3-minute question and answer by the FDA panel)
  • In-Person Open Public Speaker (approximately 3-minute timed speaking slot without slide deck or panel question/answer period)
  • Webcast Attendee (remote video / audio)

Please read ticket descriptions in Eventbrite to make the appropriate ticket selection and register for only one ticket per person.

If you need special accommodations due to a disability, please email CDER-PublicMeeting@fda.hhs.gov or contact Nicole Zelenak at 301-796-9030 no later than September 10, 2019.

Submitting Comments

Regardless of attendance at the public meeting, you can submit electronic or written comments to the public docket by November 18, 2019. Submit electronic comments to Regulations.gov. Submit written comments to the Division of Docket’s Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. All comments must be identified with the docket number FDA-2019-N-2514. The FDA may post, without change, all comments received to Regulations.gov, including any personal information provided.

Questions

If you have questions about registering for the meeting, please email CDER-PublicMeeting@fda.hhs.gov or call Nicole Zelenak at 301-796-9030, or email at nicole.zelenak@fda.hhs.gov.

Event Materials

Title File Type/Size
Opioid Public Hearing 09172019 Meeting Transcript pdf (580.38 KB)
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