The product is applied to the skin of the hoof. There are no product currently on the market that are registered and we were also one of them, until FDA stopped our prodcuts from being imported into the USA. Lameness rates are 30-35% nation wide and it seems that the off-lable use of antibiotics is also coming to an end. How can we change the mindset of the FDA, either to classify this category different or make a law for 'low-risk' products? The urgency of the matter (lameness in dairy) needs immidiate attention, but we need help? Our opinion is that we might make an effective case based on the fact that there are no approved drugs available and that allowing our product to join the group is at least consistent with the FDA's current regulatory enforcement position.
Can anyone help us?
The following link will answer some of your questions regarding the FDA approval process: http://www.fda.gov/drugs/developmentapprovalpro...
Bottom line - you need an attorney that understands this process and you need deep pockets. The State Bar of Michigan may be able to give you a referral: www.michbar.org