FAQ
Drugs
All
No. Class Title
  71   Abbreviated New Drug Application (ANDA)  

Is a structural characterization and/or safety data required for 3.2.S.3.2 Impurities section of ANDA submission?

 
  72   Abbreviated New Drug Application (ANDA)  

What coverage of data is required for a stability test in the registration of generic drugs?

 
  73   Abbreviated New Drug Application (ANDA)  

What information should be included in 3.2.S.4.5 Justification of Specification?

 
  74   Abbreviated New Drug Application (ANDA)  

What information should be provided in 3.2.P.2.1.1 for the small molecule chemical drug products?

 
  75   Abbreviated New Drug Application (ANDA)  

Where should a discussion of the performance of a functional excipient through shelf-life be included?

 
  76   Abbreviated New Drug Application (ANDA)  

Where should the relevant information on leachables and extractables of container closure system be included in?

 
  77   Abbreviated New Drug Application (ANDA)  

Where should data of constitution or dilution studies performed as part of the formal stability studies to confirm product quality through shelf-life be provided?

 
  78   Abbreviated New Drug Application (ANDA)  

For 3.2.P.3.3 Description of Manufacturing Process and Process Controls, what information is required for chemical drug products?

 
  79   Abbreviated New Drug Application (ANDA)  

What information on the reference standards or materials is required for the registration of generic drugs?

 
  80   Abbreviated New Drug Application (ANDA)  

Rather than repeating information, can only the information of reference standards be provided in 3.2.S.5 once the same information is include in 3.2.P.6?

 
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