&gt; Keep in mind. This is not an experiment, this is a clinical trial in a human.<p>(Note: I have one drug in clinical trials, for which I designed the phase I and phase II protocols, and have appeared before the FDA in support of clinical trials of new medications.)<p>Actually this is not a trial, it is considered an experiment.  Trials are controlled (not always blinded or tasted against placebo, as many people think).  Strictly speaking you cannot give an unlicensed medication without getting in trouble -- in fact permission to do a trial is actually agreement by the FDA that they won&#x27;t prosecute you for breaking this law, basically because you followed one of the procedures spelled out in the law and the FDA agreed with your proposal.<p>You are completely right on interactions.  And yes, the animals are pretty much always sac&#x27;ed at the end of the experiment, even those in placebo arms :-(<p>There are a few quasi-informal exceptions to the no unapproved administration. One is if you develop the drug yourself -- hard to prosecute.  In a modern corporation however you can&#x27;t really do that -- if you&#x27;re a research scientist developing a drug, lawyers could claim that you were forced into it by your boss (another example is that the FDA requires that QC be an independent function).  So in practice the only person who can try such a drug is the CEO.<p>In my case I was both the CEO as well as one of the developers so was confident that the <i>in vivo</i> data we had showed that I would be fine.  As a result I was a pincushion (these were true experiments in PK, diffusion etc -- I didn&#x27;t have the indication we were treating for).  The drug hasn&#x27;t yet gone for approval, but if it does, somewhere in the approval application there will be a description under &quot;previous human experience&quot;.<p>You can do other experiments and trials someplace not subject to the FDA (i.e. other countries).  Unless they are also formally part of your FDA process you can&#x27;t use them in support of approval -- but if you paid for them you have to include them as previous human experience as well.<p>And there are also various &quot;compassionate use&quot; cases though they are also somewhat-formalized now because some people try to stretch them into trial territory.  By definition they are not adequately powered.<p>There are amusing examples of previous human experience.  My favorite is someone who shall go nameless who argued in support of an erectile disfunction treatment in front of his board by dropping his trousers and injecting his penis in front of them.  I have only heard of this second hand but I bet there was quite a reaction!<p>NB for anyone else in pharma: yes I glossed a few terms like calling the NDA an &quot;approval application&quot; in the interest of clarity for those not in the industry.