What happens pre-approval? The theme of this issue made me wonder what it is that happens before approval of a new medication. Of course, it is clinical development, notably phase II and phase III studies. But many years have already passed before a drug reaches this particular development phase and many drugs have failed on the way to that point. Only 1 out of 5000 to 10 000 development compounds makes it to the market and this process can take up to 15 years.