What constitutes a First in Class designation for new molecular entities? I've seen this term on FDA documents, as well as in databases (Chembl for example), but I was curious if there are any set criteria for First in Class drugs? The easy definition, in my mind, would be a drug that hits a novel target given its indication. However, if you look at antifungal drugs, you see that drugs with the same target for the same general indication (anti-fungal) treat completely different fungal infections because of their pharmacokinetics.

Are there discrete criteria for the FDA's first-in-class designation for New Molecular Entities?

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    $\begingroup$ This page on the FDA website gives a rather terse definition: "Drugs with a new and unique mechanism for treating a medical condition". I'm not sure how that's applied in practice, though. $\endgroup$ – R.M. Jul 21 '16 at 18:36

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