FDA introductory comments: clinical studies design and evaluation issues

1. Food and Drug Administration . Innovation or stagnation? challenge and opportunity on the critical path to new medical products, Retrieved March 2004, from: http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html

2. Food and Drug Administration . Providing clinical evidence of effectiveness for human drug and biological products, guidance for industry, Retrieved 20 July 2005, from: http://www.fda.gov/cder/guidance/index.htm