FAQ
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No. Class Title
  11   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, what information should be provided for item 2 on the Type II checklist regarding referenced DMF?

 
  12   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, what information should be submitted for the stability testing section?

 
  13   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, what information must be provided for the starting material at the minimum?

 
  14   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, what is the scope of APIs for which the Type IV checklist is applicable for?

 
  15   Abbreviated New Drug Application (ANDA)  

On the ANDA Refuse to File (RTF) checklist, Item 3 of annex checklist 5 states “Does the application data include synthesis steps and process flow diagrams of the manufacturing process, drug substance specification, analytical procedures and certificates of analysis?”. Is it acceptable to provide drug substance specification, analytical procedures and certificates of analysis issued from drug product manufacturer?

 
  16   Abbreviated New Drug Application (ANDA)  

With regards to Item 11 of CMC drug product section on the ANDA Refuse to File (RTF) checklist, if water is used as solvent in the manufacturing process of a drug product, and will not remain in the final drug product, is it required to provide water test results?

 
  17   Abbreviated New Drug Application (ANDA)  

With regards to Items 6 and 12 of CMC drug product section on the ANDA Refuse to File (RTF) checklist, if analytical methods for a drug substance and a drug product follow pharmacopeia monographs, is it acceptable to provide copies of pharmacopeia monographs instead of instrumental parameters and method calculations?

 
  18   Abbreviated New Drug Application (ANDA)  

On the ANDA Refuse to File (RTF) checklist, Item 4 of CMC drug product section states “Does the application data include all of the 3.2.P Drug Product sections in the format of CTD module 3?”, is it permitted to remove those sections which are not applicable?

 
  19   Abbreviated New Drug Application (ANDA)  

If submitted application contains a drug product packaged in various sizes of plastic bottles, are technical documents related to each packaging size of drug product required at the RTF stage?

 
  20   Abbreviated New Drug Application (ANDA)  

On the ANDA Refuse to File (RTF) checklist, Items 1 and 3 of CMC drug product section mentioned “pilot scale” in the definition about the size of representative batch. What does a pilot scale stand for?

 
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