Dear Naiffer,
In view of the updation in AI limit for N-nitroso Ciprofloxacin by Health Canada and EMA as Non Mutagenic Impurity (NMI) and can be controlled as per ICH Q3A and Q3B guidelines, can you please check and confirm USFDA position regarding AI limit
Currently USFDA has published interim AI limit as 12,000 ng/day and control limit as 8 ppm with estimated duration as 03/31/25
Please check directly with the agency, as MAH you can inquire about it. Let us know when you hear back.
Dear Naiffer,
checking with the agency is kind of unclear as to whom…
If you follow the process, you go to DSS, but they only decide on drug shortage considerations, but not on a general limit change. If you file a PAS, the risk is you get a specification for your product, which you really do not want, nor need, and you are stuck in the approval decision.
Therefore it might be helpful to get an understanding on how to discuss limits with FDA in general. Any idea is highly appreciated.
Thank you.
Regards Oliver