GL - FDA is particularly important because it is considered to be the highest authority in Drug Administration.
In my opinion the largest market for TIS will be China and India - Specially India which is the Diabeties Capital of the world. Over the next few years these markets will be much bigger than USA.
Since they dont have any regulatory approval process of their own (which is well defined), they do follow the FDA approval. i.e. Drugs which have FDA approval have practically no issues getting into these markets.
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