1. Approval of New Drugs in the United States
2. Status of off‐label use of drug and its regulations in the US and Japan since late 1990s;Fukuzawa M.;Pharm. Med. Dev. Regul. Sci.,2011
3. Systematic Review: Reliability of Compendia Methods for Off-Label Oncology Indications
4. Ministry of Health and Welfare Japan.Handling of prescription drugs in insurance medical care (in Japanese) (1980). Accessed March 14 2021.
5. Pharmaceuticals and Medical Devices Agency Japan.Prescription drugs for reimbursement by health insurance coverage after review of pre‐evaluation on public knowledge‐based applications by Pharmaceutical Affairs and Food Sanitation Council during non‐approved period in Japan (in Japanese). Accessed March 14 2021.