The Post Approval Monitoring Program (PAMP) for POSILAC®
Click here for the 2001 Report
In November 1996, Monsanto received unanimous support from the
Veterinary Medicine Advisory Committee (VMAC) of the Food and Drug
Administration regarding the results of the most extensive post-approval
monitoring program (PAMP) ever conducted for an animal pharmaceutical
product.
The program was designed to collect additional information about
supplementation with POSILAC® in on-farm settings,
evaluate the adequacy of established product use instructions and
determine whether the product affects the quality or safety of milk.
PAMP was voluntarily conducted and developed by Monsanto, with final
review and acceptance from the FDA.
In 1994, the year POSILAC entered the market, there was no difference
in the percentage of milk discarded due to violative residues, as
compared to 1992 and 1993.
During the two-year period, POSILAC was studied in 28 commercial
dairy herds in four regions across the country. The study, representing
1,213 cows, focused on the general herd health in commercial operations
ranging from 40 to more than 1,500 head per herd.
The results of PAMP confirmed the safety of POSILAC for cows and
the safety of the milk supply from cows supplemented with POSILAC.
Click here for the 2001 Report
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