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  141   Investigational New Drug Application(IND)  

For ongoing clinical trials, is it required to submit an amendment application to the TFDA for change of investigational drug batch number?

  
  142   Investigational New Drug Application(IND)  

(1) For ongoing clinical trials, the shelf-life of an investigational drug is extended, such as from 2 years to 3 years, is it required to submit an amendment application to the TFDA for extension of shelf-life? (2) Is re-labelling a permissible way to modify the shelf-life for the investigational drug?

 
  143   Investigational New Drug Application(IND)  

For ongoing clinical trials, is it required to submit an amendment application to the TFDA for change of placebo batch number?

  
  144   Investigational New Drug Application(IND)  

How to calculate the endotoxin limit for parenteral drugs?

  
  145   Investigational New Drug Application(IND)  

How many stability batches of investigational drug are required in an investigational new drug (IND) application?

  
  146   Investigational New Drug Application(IND)  

If the drugs for investigational drug or active control/concomitant drug use have not been approved for marketing in Taiwan, are the certificates of analysis of drug substance, drug product and placebo/active control/concomitant drug submitted in an investigational new drug (IND) application?

  
  147   Investigational New Drug Application(IND)  

Are stability data required for the submission of an investigational new drug (IND) application?

  
  148   Investigational New Drug Application(IND)  

Is there a basis to set the acceptance criteria of the organic impurities in the specifications of drug substance and drug product for investigational new drug (IND) applications?

  
  149   Investigational New Drug Application(IND)  

What CMC data of active controls or concomitant drugs should be submitted for investigational new drug (IND) applications?

  
  150   Investigational New Drug Application(IND)  

How to check information regarding ongoing clinical trials in Taiwan?

  
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