https://www.proz.com/personal-glossaries/entry/2622577-%E3%80%8A%E7%94%A8%E4%BA%8E%E6%89%B9%E5%87%86%E7%9A%84%E4%B8%8A%E5%B8%82%E6%96%B0%E8%8D%AF%E7%94%B3%E8%AF%B7%EF%BC%9B%E5%AE%8C%E5%85%A8%E5%9B%9E%E5%BA%94%E5%87%BD%EF%BC%9B%E5%AF%B9%E6%9C%AA%E6%89%B9%E5%87%86%E7%94%B3%E8%AF%B7%E7%9A%84%E4%BF%AE%E6%AD%A3%E3%80%8B-applications-for-approval-to-market-a-new-drug-complete-response-letter-amendments-to-unapproved-applications