DNAprint Genomics (DNAG)

[mingwan0]

Yes, this is better. However, if you look at the guidelines for submission format on page 11 it is still rather unstructured. The FDA seems to want to infer the relevant submission format(s) from experience rather than try to define a format(s) and then implement it. There is no mention of race or ancestry in this document at all, although population is mentioned in relation to variable drug response. It is undoubtedly a step forward, but in some ways a missed opportunity as well - they could have gone further IMO.