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  121   New Drug Application (NDA)  

【ST】Under what situations can the efficacy of a single pivotal study be considered sufficient to support the registration of a new drug?

  
  122   New Drug Application (NDA)  

【ST】In CDE’s opinion, what is the requirement of NDA efficacy evidence?

  
  123   New Drug Application (NDA)  

【ST】In addition to the evidence criteria for efficacy, what additional considerations would be important for NDA review?

  
  124   New Drug Application (NDA)  

【ST】 What should the key statistical considerations be when reviewing a clinical study report?

 
  125   New Drug Application (NDA)  

【ST】What are the review points of the pivotal trial protocol and its amendments?

  
  126   New Drug Application (NDA)  

【ST】What are the statistical considerations for review of new drug application (NDA)?

 
  127   New Drug Application (NDA)  

What nonclinical toxicology studies are recommended for the development of biotechnology-derived pharmaceuticals?

  
  128   New Drug Application (NDA)  

Under which circumstances, the applicant need to provide full report of carcinogenicity study for a new molecular entity marketing authorization?

  
  129   New Drug Application (NDA)  

Which nonclinical Pharm/Tox study data need to be provided for marketing authorization for a new indication of listed drugs?

  
  130   New Drug Application (NDA)  

【Clinical】Regarding Article 38-2 of the Regulations for Registration of Medicinal Products, how to defined the “valid Taiwanese subjects” in a clinical trial to fulfill the requirement?

  
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