Thursday, November 06, 2003 12:13:45 AM
As regards the "Guidelines" though, some data is "required". Other information is "voluntary". But again, I have worked with the government in this country long enough to know that they take their "guidance" seriously. For instance, the DNR in Wisconsin has "guidance" concerning electrical design for explosive areas. You are free to submit a design that is in conflict with the "guidance", at which point they will send it back and "suggest" that you rethink your approach! lol
Secondly, the value of this guidance to DNAP is that it creates a regulatory path for them to present their data, either alone, or in conjunction with a research collaborator or pharmaceutical partner. In other words, a line of communication has been opened with the FDA, at the request of the FDA, that the company can now walk through to make their best case to the agency. And the document made the point that they expect this to be particularly relevant for certain oncological treatments and diagnostics.
I'm afraid we'll have to disagree as to the size of the step. I am very encouraged by this action. It will be interesting to view the comments as they are published.
Later my friend,
W2P
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