Friday, January 27, 2012 1:37:29 PM
You stated a personal opinion that the FDA is the only regulator in the world to focus on safety and efficacy and that no other regulator focuses on efficacy - I say that personal opinion is incorrect and misleading. Some may find that difficult to accept, most would not and I expect you are in the latter group as you are obviously a person of intelligence.
QUOTE
Health Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the potential health benefits and risks posed by all drugs and health products. Our highest priority in determining the balance is public safety. UNQUOTE
Sooooo, the fact is that Health Canada states its role as "ensuring you have access to safe and effective drugs and health products." And further states, "Our highest priority in determining the balance (between those two) is public safety." Separate statements, safety highest, on balance. All good.
New fact-old news - there is most probably not a pharma or device company globally that does not grind its teeth and smile at the same time when dealing with the FDA because of time and outrageous expense in obtaining approvals. On balance, the FDA must be made up of thousands of dedicated and responsible experts and administrators.
The results? No melamine in a baby formula as happened in China, under its regulatory process of bribes and whoyaknow in the PRC communist party. An issue which led to a couple of suicides and executions of Chinese administrators.
Let's hear it for the FDA and Health Canada and safety and efficacy - isn't melamine what kitchen counter-tops used to be made of? Pulse therapy I am finding has been around a long time. I know ActiPatch worked on my sprained ankle. Canada is the US' biggest trading partner with a 3,000 mile long unprotected border and 1st world in every way. It is not a 3rd world banana or sand dictatorship handing out regulatory approvals for bribes. I told my doctor I was using ActiPatch, he was amazed and looked into it for me. He stopped when he saw my ankle 3 days later. Good enough for me. And isn't there a BIEL product already approved for post-opthalmic surgery, I think I read that somewhere, maybe here?
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