Date:
October 29, 2024
Time:
8:00 AM - 5:00 PM ET
Location:

Event Location

FDA Headquarters
FDA headquarters in White Oak, MD

10903 New Hampshire Ave
Silver Spring, MD 20903
United States


What is an advisory committee?

Advisory committees provide independent expert advice to the FDA on broad scientific topics or on certain products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so. Please see, "Advisory Committees Give FDA Critical Advice and the Public a Voice," for more information.

FDA will be hosting this advisory committee meeting on October 29, 2024.

Center: Center for Drug Evaluation and Research

Time and Location 

This meeting is scheduled to start at approximately 8 a.m. Eastern Time and will be held at FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002. The public will also have the option to participate via an online teleconferencing and/or video conferencing platform, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.

Agenda

The Committee will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: Ibutamoren mesylate, L-theanine, Ipamorelin-related bulk drug substances (Ipamorelin acetate and Ipamorelin (free base)), and Kisspeptin-10. The Committee will also discuss a revision FDA is considering to the Withdrawn or Removed List. Specifically, FDA is considering whether to amend 21 CFR 216.24 to add an entry to the list for certain drug products containing Hydroxyprogesterone caproate.

Meeting Materials

FDA intends to make meeting materials 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 meeting materials on its website prior to the meeting, the meeting materials will be made publicly available on FDA’s website at the time of the advisory committee meeting and additional copies will be available at the meeting location. The virtual portion of the meeting will include slide presentations with audio and video 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 September 2024. More information regarding the docket will be available once the Federal Register notice for this meeting publishes.

Interested persons will have an opportunity to request slots to make presentations during the open public hearing session of the meeting.  Additional information on such presentations, including instructions on how interested persons can submit requests for presentation slots, will be provided in FDA’s forthcoming Federal Register notice for the meeting.

Webcast Information

CDER plans to provide a free of charge, live webcast of the upcoming 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

Takyiah Stevenson, PharmD
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
WO31-2417
Silver Spring, MD  20993-0002
Phone: 240-402-2507
Email: PCAC@fda.hhs.gov

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.

Press Inquiries
For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov 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).