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

If a copy of CEP provided by the manufacturer of the drug substance is submitted, can residual solvent testing be waived in the specification of the drug substance issued by the manufacturer of the drug product?

 
  62   Abbreviated New Drug Application (ANDA)  

There are several container closure sizes/fills for one drug product. Can we produce one commercial scale batch of bulk product and then fill or package the bulk product in different sizes of the same container closure system?

 
  63   Abbreviated New Drug Application (ANDA)  

Is splitting of tablets testing considered an essential part of release and shelf-life specification for scored tablets with one or more breaklines?

 
  64   Abbreviated New Drug Application (ANDA)  

Is endotoxin testing considered an essential part of shelf-life specification to confirm parenteral products to be pyrogen-free?

 
  65   Abbreviated New Drug Application (ANDA)  

How to perform the repeatability of analytical method validation?

 
  66   Abbreviated New Drug Application (ANDA)  

One identification test method of current drug product specification is to compare the retention time in the assay by HPLC. Can the retention time of HPLC in other test items be added as another identification test method?

 
  67   Abbreviated New Drug Application (ANDA)  

If the long-term and accelerated stability data in low humidity condition of aqueous-based products packaged in semi-permeable containers were provided, should water loss evaluation still be assessed?

 
  68   Abbreviated New Drug Application (ANDA)  

The analytical method of related substances for drug substance is by HPLC. Is it necessary to prepare the standard solution with the same concentration as that of 100% impurity specification?

 
  69   Abbreviated New Drug Application (ANDA)  

Nitrogen filled in injections does not react with drug product and is not absorbed by human body. Is it necessary to be listed in the composition statement in the application form?

 
  70   Abbreviated New Drug Application (ANDA)  

According to Regulations for Registration of Medicinal Products, Article 9-4, specifications and test methods should be provided for coloring agents. However, if the coloring agents are components of hard capsules, are the specifications and test methods for the coloring agents still required in the drug product application?

 
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