1. Anonymous 1992a FDA's policy statement for the development of new stereoisomeric drugs http://www.fda.gov/cder/guidance/stereo.htm
2. Anonymous 1992b Orphan Drug Regulations 21 CFR PART 316 http://www.fda.gov/orphan/about/odreg.htm
3. Well-characterized biologies would be regulated under FD&C Act by Kassebaum FDA Reform Bill;Anonymous;F-D-C Reports (Pink Sheets),1996