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  4. April 19, 2023: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement - 04/19/2023
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Advisory Committee Meeting

Event Title
April 19, 2023: Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee Meeting Announcement
April 19, 2023

Date:
April 19, 2023
Time:
9:00 AM - 5:30 PM ET

Center: Center for Drug Evaluation and Research

Location: Please note that due to the impact of this COVID-19 pandemic, all meeting participants will be joining this advisory committee meeting via an online teleconferencing platform.

Agenda

The meeting presentations will be heard, viewed, captioned, and recorded through an online teleconferencing platform. The committee will discuss postmarketing requirement (PMR) 3033-11, issued to application holders of new drug applications (NDAs) for extended-release and long-acting (ER/LA) opioid analgesics to evaluate long-term efficacy of opioid analgesics and the risk of opioid-induced hyperalgesia. The discussion will focus on a clinical trial designed to address these objectives.

Meeting Materials

FDA intends to make background material and the link to the live webcast available to the public no later than two (2) business days before the meeting in the Event Materials section of this web page. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available on FDA’s website at the time of the advisory committee meeting. The meeting will include slide presentations with audio components to allow the presentation of materials in a manner that most closely resembles an in-person advisory committee meeting.

Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

FDA intends to publish a Federal Register notice and establish a docket for public comment on this meeting by March 2023. More information regarding the docket will be available once the Federal Register notice for this meeting publishes.

Those individuals interested in making formal oral presentations during the open public hearing session of the meeting should follow the instructions in the Federal Register Notice when it publishes.

Webcast Information

CDER plans to provide a free of charge, live webcast of the Anesthetic and Analgesic Drug Products Advisory Committee meeting. If there are instances where the webcast transmission is not successful, staff will work to re-establish the transmission as soon as possible. Further information regarding the webcast, including the web address for the webcast, will be made available no later than two (2) business days before the meeting in the Event Materials section of this web page.

CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.

Contact Information

  • Rhea Bhatt
    Center for Drug Evaluation and Research
    Food and Drug Administration
    10903 New Hampshire Avenue
    WO31-2417
    Silver Spring, MD 20993-0002

    Phone: 301-796-2894
    Email: [email protected]
  • FDA Advisory Committee Information Line
    1-800-741-8138 (301-443-0572 in the Washington DC area) Please call the Information Line for up-to-date information on this meeting.
  • For press inquiries, please contact the Office of Media Affairs at [email protected] or 301–796–4540.

 

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s website or call the committee’s Designated Federal Officer (see Contact Information) to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact the committee’s Designated Federal Officer (see Contact Information) at least 7 days in advance of the meeting.

Answers to commonly asked questions including information regarding special accommodations due to a disability may be accessed at: Common Questions and Answers about FDA Advisory Committee Meetings.

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at Public Conduct During FDA Advisory Committee Meetings for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).

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