1. 21 CFR 56. Available at: http://www.access.gpo.gov/nara/cfr/waisidx_00/21cfrv1_00.html.
2. National Cancer Institute, National Institutes of Health, NCIDEA: data and safety monitoring of clinical trials (Available at), http://deainfo.nci.nih.gov/grantspolicies/datasafety. html (07-09-99 Updated).
3. US Food and Drug Administration, Department of Health and Human Services, Center for Devices and Radiological Health. Guidance for the content of premarket notification for metal expandable biliary stents (updated 3-21-00). Available at: http://www.fda.gov/cdrh/ode/bistent.html.
4. Carvedilol and the Food and Drug Administration (FDA) approval process: the FDA paradigm and reflections on hypothesis testing;Fisher;Contr Clin Trials,1999
5. Carvedilol and the Food and Drug Administration approval process: an introduction;Fisher;Contr Clin Trials,1999