1. Kroll D. Josh Hardy going home after getting Chimerix anti-viral drug. http://www.forbes.com/sites/davidkroll/2014/07/17/josh-hardy-going-home-after-getting-chimerix-anti-viral-drug/. Published 2014. Accessed August 6, 2015.
2. Pogorelc D. Cancer patient’s compassionate use conundrum incites a social media ambush on BioMarin. MedCityNews. September 24, 2013.
3. Iudicello A, Alberghini L, Benini G, Mosconi P. Expanded Access Programme: looking for a common definition. Trials. 2016;17:1–10.
4. Hamel MB, Darrow JJ, Avorn J, Kesselheim AS. New FDA breakthrough-drug category—implications for patients. N Engl J Med. 2014;370:1252–1258.
5. Food and Drug Administration. Investigational new drug, antibiotic, and biological drug product regulations; treatment use and sale. Final rule. Fed Regist. 1987;52:19466–19477.