Based on current clinical practices, the Technical Guidelines is about the threads for thought and specific elements in designing the clinical research on new drugs for acute myeloid leukemia (AML).
The Technical Guidelines only represents CDE's current opinions. Some contents in the Technical Guidelines may not be adopted because of the changes of clinical practice. Therefore, the Technical Guidelines is a reference for drug applicants and investigators with no legal effects. While applying the Techncial Guidelines into practice, applicants and investigators should also refer to ICH's guidelines and other technical guidelines issued in or outside China.