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3. Code of Federal Regulations.§601.41.https://www.ecfr.gov/cgi‐bin/text‐idx?SID=c03234aa22abbed0380923a4cc6ab001&mc=true&node=se21.7.601_141&rgn=div8. Accessed March 10 2021.
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5. Ministry of Health Labour and Welfare.Implementation of conditional early approval system for pharmaceutical products 2017(in Japanese).https://www.pmda.go.jp/files/000220723.pdf. Accessed March 10 2021.