Advisory Committee Meeting | In Person
Event Title
April 23, 2018: Science Board to the FDA Meeting Announcement
April 22, 2018
- Date:
- April 23, 2018
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.
| Center | Date | Time | Location |
|---|---|---|---|
| OC | April 23, 2018 | 9:00 a.m. to 4:30 p.m. |
Food and Drug Administration |
For those unable to attend in person, the meeting will also be webcast: Webcast link
Information regarding accommodations due to a disability, visitor parking, and transportation may be accessed at: Public Meetings at the FDA White Oak Campus. Please note that visitors to the White Oak Campus must enter through Building 1.
Agenda
The Science Board will: hear a report from the Center for Biologics Evaluation and Research Program Review Subcommittee; hear about FDA’s Patient Affairs Initiative; and discuss how the agency can leverage its existing tools and authorities, and work with stakeholders, to better address the complex scientific, public health and technology challenges it faces today.
Meeting Materials
FDA intends to make the complete background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
- Background Material
Public Participation
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.
- Written submissions may be made to the contact person on or before April 18, 2018.
- Oral presentations from the public will be scheduled between approximately 3:30 and 4:30 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before April 10, 2018.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by April 11, 2018.
Contact Information
Rakesh Raghuwanshi
Office of the Chief Scientist
Office of the Commissioner
Food and Drug Administration
White Oak Bldg 1, Room 3309
10903 New Hampshire Ave
Silver Spring, Maryland 20993
Phone: 301–796-4769
Fax: 301-847-3536
E-mail: rakesh.raghuwanshi@fda.hhs.gov
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 Advisory Committees Web page and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting.
- FDA Advisory Committee Information Line 1-800-741-8138
(301-443-0572 in the Washington DC area).
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 Rakesh Raghuwanshi at (301) 796-4769 at least 7 days in advance of the meeting. FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site 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).
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).
Event Materials
| Title | File Type/Size | Source Organization |
|---|---|---|
| Science Board Meeting Minutes- April 23, 2018 | pdf (39.65 KB) | |
| Science Board Meeting Transcript- April 23, 2018 | pdf (719.96 KB) |