FDA Announces Upcoming Veterinary Medicine Advisory Committee Meeting to Discuss ProHeart® 6
January 28, 2010
The Food and Drug Administration is announcing today the Veterinary Medicine Advisory Committee (VMAC) which will be held on March 24th, 2010 from 8:30 a.m. to 5:00 p.m. at the Rockville Hilton in Rockville Maryland.
The VMAC will be discussing the current Risk Minimization Action Plan (RiskMAP) for ProHeart® 6 based on data generated during the first 18 months of marketing under a RiskMAP. The purpose of the RiskMAP is to ensure safe and appropriate use of ProHeart® 6 in order to achieve the maximum benefits of heartworm prevention while minimizing the risk to dogs. CVM will be presenting the results of our analysis of 18 months of data generated under the RiskMAP and are seeking feedback from the expert panel.
The meeting is open to the public and interested persons may present data, information, or views, orally or in writing, on the issues pending before the committee. Written submissions may be made to Aleta Sindelar, CVM (HFV-3), FDA, 7519 Standish Place, Rockville, MD 20855 on or before March 17, 2010.
Oral presentations from the public will be scheduled between approximately 1:00 p.m. and 2:00 p.m. on March 24. Interested persons should notify Aleta Sindelar on or before March 9, 2010 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. Time allotted for each presentation may be limited. The contact person will notify interested persons regarding their request to speak by March 10, 2010.
Additional background information will be made available and posted in advance of the meeting as soon as it becomes available. Up-to-date information on the VMAC meeting is also available on the FDA Advisory Committee Information Line at 1-800-741-8138 or 301-443-0572 (code number 3014512548).
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 Aleta Sindelar at least 7 days in advance of the meeting.
Federal Register Notice of 2010 Veterinary Medicine Advisory Committee Meeting ProHeart® 6 RiskMAP - September 2008(PDF - 5.2MB) [ARCHIVED]
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Veterinary Medicine Advisory Committee