1. US Food and Drug Administration. Guidance for industry. Enrichment strategies for clinical trials to support approval of human drugs and biological products. 2012. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332181.pdf. Accessed January 8, 2018.
2. US Food and Drug Administration. Guidance for industry developing targeted therapies in low-frequency molecular subsets of a disease guidance for industry. December 2017 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588884.pdf. Accessed December 20, 2017.
3. US Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA efforts to support more efficient development of targeted therapies. December 15, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm589248.htm. Accessed December 20, 2017.