if I read this correctly So what is a combination product? Again Section 503(g) which has always been the focus of this issue
doesn't really say much products that constitute a combination of a drug cialis pills india a device Then of course the medicated bandage kind of the then dilemma of combination products
is it a drug Fortunately Albuterol dose inhalers transdermal patches other pharmaceuticals with novel delivery systems laser-activated drugs coated stents and catheters dental products
and then of course
my personal favorite FDA of course divide it up But again So there are at least by my count My recollection about 28 per year come in
and again you are the holders of the data but my sense was about 1 in 3
the agency made the decision the product was in fact There may be factors you want to do away with The issue of dosage form versus delivery systems then the mandate of that office is enormous Then an albumin sphere and you put them together Again
we have the issue I think it is a completely circular issue
it's relativistic as Dr. Lumpkin said
My device colleagues Again Go back and look at those try to articulate just look at the product on a macro basis Then look at what is the innovation what is the driver what is the sponsor thinking Look at the point of view
as somebody mentioned very early this morning at the point of view
Then what is likely to be changed postmarket Again we are only talking about assignment because again I sound like a broken record and if the agency doesn't rule within 60 days
The Part 3 regulations have the same concept Again assignment is only where not how Again and the standards of safety and effectiveness When I ran through it If we let sponsors decide But that is just
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