The Food and Drug Administration has posted background information in advance of a meeting on the Risk Minimization Act Plan (RiskMAP) for Pfizer’s ProHeart 6.
The Veterinary Medicine Advisory Committee will meet March 24 to recommend modifications, if any, to the risk minimization and restricted distribution program for the injectable heartworm treatment. The panel will present FDA analysis of 18 months of data collected under the RiskMAP and will seek feedback from a panel of experts.
A voluntary recall was issued for ProHeart 6 in September 2004 to address federal safety concerns.
The background material is available here.
The committee will meet from 8:30 a.m. to 5 p.m. Wednesday, March 24, at the Rockville Hilton in Rockville, Md.
Oral presentations from the public are set for 1 to 2 p.m.