3 ms·
>One of my former colleagues once made a "drug" where the excipient actually was therapeutically valuable while the listed API was barely better than placebo. L
by icelancer 9y ago
>One of my former colleagues once made a "drug" where the excipient actually was therapeutically valuable while the listed API was barely better than placebo. Luckily we didn't submit it for approval.
That seems... ridiculously illegal.
- gumby 9y agoWhy should it be illegal? The submission process would be the same. The reason I sail "luckily" was just that it would be complicated. I believe there are some topical OTC drugs that work this way :-( Or did you think making unlicensed drugs is illegal? Of course it isn't -- that's what drug development IS. It's not legal to give such a drug to humans without a valid IND that hasn't been rejected by the FDA but formulating, doing in vitro testing and animal in vivo testing is all perfectly legit.