UPDATED INFORMATION (as of 10/16/13):
The meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology scheduled for October 31, 2013 is cancelled due the government shutdown because FDA's carryover user fee funding was not available for this activity.
|CDER||October 31, 2013||8:00 a.m. to 5:00 p.m.||FDA White Oak Campus|
The Great Room (Rm. 1503)
White Oak Conference Center
10903 New Hampshire Avenue
Silver Spring, Maryland
There will be two topics presented to the committee for their discussion and consideration. During the first session, the Office of New Drug Quality Assessment will lead a discussion on the challenges and opportunities of continuous manufacturing for pharmaceutical products. Speakers from the Agency, academia, and industry will provide their thoughts on scientific and regulatory challenges for implementing continuous processes for drug substance and drug product manufacturing.
During the second session, the Committee will receive an informational only update from the Office of Generic Drugs on what Agency actions/changes have taken place following previous discussions with the committee pertaining to quality and bioequivalence concerns for narrow therapeutic index drug products. This will be an awareness topic and there will not be formal Committee discussion or recommendation.
FDA intends to make 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.
Public Participation Information
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 October 16, 2013.
- Oral presentations from the public will be scheduled between approximately 10:45 a.m. to 11:45 a.m. on October 31, 2013. Those desiring to make 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 October 7, 2013.
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 October 8, 2013.
CDER plans to provide a free of charge, live webcast of the October 31, 2013, meeting of the Advisory Committee for Pharmaceutical Science and Clinical Pharmacology. While CDER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, 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 at least 2 days in advance of the meeting at the following website: 2013 Meeting Materials, Pharmaceutical Science and Clinical Pharmacology Advisory Committee.
CDER plans to post archived webcasts after the meeting, however, in cases where transmission was not successful, archived webcasts will not be available.
- Kalyani Bhatt, BS, MS
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
- 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
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 and call the FDA Advisory Committee Information Line 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 physical disabilities or special needs. If you require special accommodations due to a disability, please contact Kalyani Bhatt at (301) 796-9001 at least 7 days in advance of the meeting.
Information regarding ground transportation, airport information, lodging, driving directions and visitor parking, and security can be accessed at: Public Meetings at the FDA White Oak Campus.
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).