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TODAY: FDA Public Meeting To Discuss DNA From PCV1 in Rotavirus Vaccines

Posted May 07 2010 12:00am

Rotateq-logo Vaccines and Related Biological Products Advisory Committee Meeting Announcement FDA Site for Full Meeting Details  (Note, the announcement does not appear to have been updated to include the findings announced yesterday of both PCV1 and PCV2 in Merck's RotaTeq.)

Webcast Open To Public Register HERE

May 7, 2010 from 8:00 a.m. to approximately 4:30 p.m. Hilton Hotel DC North/Gaithersburg
620 Perry Pkwy, Gaithersburg, Maryland 20877


On May 7, 2010, in the morning, the committee will review and discuss available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline and indicated for the prevention of rotavirus gastroenteritis in infants. The committee will discuss what additional steps should be considered to address this finding. In the afternoon, the committee will discuss and make recommendations on the use of advanced analytical detection methods not currently applied for the characterization of cell substrates, viral seeds, and other biological materials used in the production of viral vaccines for human use.

Meeting Materials

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 May 4, 2010
Oral presentations from the public will be scheduled between approximately 10:50 a.m. to 11:20 a.m. and 2:45 p.m. to 3:15 p.m. 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 April 29, 2010. 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 30, 2010.

Contact Information
Christine Walsh, R.N.
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-0314 FAX: 301-827-0294

FDA Advisory Committee Information Line
1-800-741-8138  (301-443-0572) code 3014512391. Please call the Information Line for up-to-date information on this meeting.
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.

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 Web site and call the appropriate advisory committee hot line/phone 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 Christine Walsh or Denise Royster 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 meetings2.

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

Official FR Notice

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