Health committee  I'll add very quickly, because it goes to something I raised earlier, that the life cycle changes, and having attachments to that.... I'll give you a good example. Vitamin K, until recently, was a prescription drug. There's a lot of history behind that. Some of the attachments t

Health committee  Manufacturers ultimately bear the burden of safety and efficacy and quality. The regulations that are in play are there to protect the public from fraud and danger. Actually, it goes to the heart of a lot of issues we talked about, such as cost recovery. Are the activity levels

Health committee  Regarding your earlier question about the impact of the progressive licensing framework, one of the core messages we'd like to deliver is that we don't want to lump all products together in one framework. The progressive licensing framework, if you look at the life cycle that the

Health committee  I will just add something very quickly. I'm always intrigued by the 10% number, because if you know that 10 in 100 are reported, you must have known that there were 100 to begin with. So the number itself is not that meaningful to me, other than the fact that it is underreported

Health committee  Yes, they do.

Health committee  Actually, I was going to define it more broadly. It's any reaction that would require some medical intervention. I'll give you an illustrative example of what would be and would not be--say, a poisoning incident--because this is more commonly part of the entire database of advers

Health committee  I think there are two things here. One was earlier said by Dr. Fontana, that nomenclature is very important in terms of trying to understand what we mean by adverse events. Most certainly the serious unexpected adverse events, which are the most important ones that are reported,

Health committee  Thank you very much. Good morning, ladies and gentlemen of the committee. I thank you for this opportunity to appear before you today. This is Robert White, a colleague of mine and our director of scientific and regulatory affairs. I am David Skinner. l am president of NDMAC.