4 ms·
> "if successful she plans to roll out a public offering in three to five years despite neither treatment being FDA approved" Is it legal to offer a product th
by koopuluri 11y ago
> "if successful she plans to roll out a public offering in three to five years despite neither treatment being FDA approved"
Is it legal to offer a product that hasn't gone through FDA as long as consumers sign their acknowledgement?
- maxerickson 11y agoIf you do it outside the US the FDA is irrelevant. It might be necessary to be a little careful with what entity is promoting the treatment and so on.
- gojomo 11y agoProbably not in the US. But the workaround is already in the article: do it in another more-favorable jurisdiction. Medical tourism for price reasons is already a big thing. People are also traveling to Mexico or South Korea for stem-cell treatments unavailable in the US. Startups might also find US jurisdictions that want to carve out more experimental freedom than the FDA's defaults, as with stem cells in Texas: http://www.bloomberg.com/bw/articles/2013-01-03/stem-cell-showdown-celltex-vs-dot-the-fda http://www.bloomberg.com/bw/articles/2013-01-03/stem-cell-sh...