Excellent - I am so pleased to be able to address source documents rather than theories.
1. Asian generally means orientals. There are lots of differences between Caucasians and Orientals. Not many between Indians and Caucasians. In fact, the higher you go in the caste system (oh, no, now I've done it), the closer the similarity. Brahmins are more than 99% genetically identical to Europeans. This is not surprising if you know Indian history.
2. As the FDA says, they want racial data on ALL studies on ALL populations as the demand for identifying genetic basis for efficacy and safety increases. The web page gives examples, and so I won't repeat it here. The web page does not address specifically from which areas/countries it will accept data without bioequivalence studies.
very interesting... considered that many people self identify themselves, I wonder how accurate studies are unless they actually use a dna-type test to determine the percentages of genes. It's pretty fascinating if one is a geneticist I suppose.