REFERENCES
- U.S. Food and Drug Administration. 1987. Part 312—Investigational new drug application, Sec 312.3 Definitions and interpretations, (b) Clinical investigation. Code of Federal Regulations Title 21. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.3
- U.S. Food and Drug Administration. 2009. Final rule 21, CFR Parts 312 and 316. Expanded access to investigational drugs for treatment use. Federal Register 74(155): 40900. Available at: http://www.gpo.gov/fdsys/pkg/FR-2009-08-13/pdf/E9-19005.pdf
- Walker, M. J., W. A. Rogers, and V. Entwistle. 2014. Ethical justifications for access to unapproved medical interventions: An argument for (limited) patient obligations. American Journal of Bioethics 14(11): XX–XX.