Clinical trials conducted between regulatory submission of an NDA (New Drug Application) and approval of a regulatory dossier for marketing authorization.
Clinical trials conducted between regulatory submission of an NDA (New Drug Application) and approval of a regulatory dossier for marketing authorization.
旨在向药审机构递交了新药注册申请之后到申请药物被批准上市之前的一段时间内进行的相关药物临床试验.