1. US Department of Health and Human Services US Food and Drug Administration.Guidance for industry: providing clinical evidence of effectiveness for human drug and biological WebPage; 1998. Accessed July 2 2020.
2. US Department of Health and Human Services US Food and Drug Administration.Demonstrating substantial evidence of effectiveness for human drug and biological products guidance for industry WebPage; 2019. Accessed February 12 2021.
3. US Department of Health and Human Services US Food and Drug Administration.Code of federal regulations title 21: food and drugs subpart H: accelerated approval of new drugs for serious or life‐threatening illnesses. WebPage; 2017. Accessed November 24 2017.
4. US Department of Health and Human Services US Food and Drug Administration.Fast Track breakthrough therapy accelerated approval priority review WebPage; 2018.Accessed February 12 2021.
5. US Department of Health and Human Services US Food and Drug Administration.Guidance for Industry: Expedited Programs for Serious Conditions–Drugs and Biologics WebPage; 2014. Accessed December 13 2017.