These proposed changes are concerned with "intended use" and how it is proven. There are, for example, products that are supplied seemingly for cosmetic use, but in reality are being supplied and used for therapeutic purposes. So the FDA is tightening up the system under which the the supplier can say we only know about cosmetic use, and don't intend for the product to be used for therapeutic purposes (and so escape the regulatory net or some part of it).
This has absolutely nothing to do with MSB's situation. Everyone knows what the intended uses are -- and they are all theraputic.
I don't see these proposed changes as being in any way directed to "off label" use.
In short, nothing to see here!
Full steam ahead.....
Cell Therapy News/Articles, page-6821
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