1. www.fda.gov/.../GuidanceComplianceRegulatoryInformation/Guidances/ucm071577.pdf; [accessed 10.05.10].
2. http://www.access.gpo.gov/su_docs/fedreg/a070814c.html;
3. Health and Human Services Department, Food and Drug Administration [Human drugs, biological products, and medical devices] [accessed 10.05.10].