I haven't read any detailed treatment of the subject but the book described here sounds like it would give you a very good overview of the issues and regulatory

I haven't read any detailed treatment of the subject but the book described here sounds like it would give you a very good overview of the issues and regulatory consequences [1]https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1383764/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1383764/