Ok, reading through this thread I have some questions for anyone who may know the answers. I tried to research them myself but got frazzled by all the crap the searched returned or by the lack of info on the FDA websites.
From what I understand the FDA does not regulate peptides. So why would the researchers need FDA approval? Once it's FDA approved does it become to be considered a "drug"? Couldn't they just sell liscenses to labs and make a ton of money without FDA approval? The potential market for something like this is huge so why would anyone want FDA approval/regulation? Does FDA approval provide some type of protection from litigation? Sorry, I am just trying to figure out why the patent holders wouldn't just skip FDA approval and all the money it takes to get it and just liscense it to be sold to the public?
From what I understand the FDA does not regulate peptides. So why would the researchers need FDA approval? Once it's FDA approved does it become to be considered a "drug"? Couldn't they just sell liscenses to labs and make a ton of money without FDA approval? The potential market for something like this is huge so why would anyone want FDA approval/regulation? Does FDA approval provide some type of protection from litigation? Sorry, I am just trying to figure out why the patent holders wouldn't just skip FDA approval and all the money it takes to get it and just liscense it to be sold to the public?