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2. FDAMA, https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDAMA/FullTextofFDAMAlaw/default.htm (accessed 06.01.17).
3. Section 709 (21 U.S.C. 379a) Presumption of Jurisdiction, https://www.gpo.gov/fdsys/pkg/USCODE-2010-title21/html/USCODE-2010-title21-chap9-subchapVII-partA-sec379a.htm (accessed 06.01.17).
4. Clinical Trial Authorisation Framework in Europe—Presentation by Dr. Chantel Belorgey, http://www.emea.europa.eu/docs/en_GB/document_library/Presentation/2010/06/WC500093373.pdf (accessed 06.01.17).
5. US FDA Forms, https://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/ListFormsAlphabetically/default.htm (accessed 06.01.17).