Dear all,
Good morning.
Case: Product was approved when Nitrosamine impurities not available.It is a recent requirement as per the FDA.
API has higher value of Nitrosamine limit. We have filed a supplement application based on surrogate data for a higher limit proposal. However, the FDA denied it as the FDA has already published the limit in NDSRI Table 1.
FDA asked to implement things within one year. Is it possible to ask FDA for Extention? What is the procedure to get extention? Does it impact the already marketed product?
Please share valuable input.
Regards,
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sapna rathi
Regulatory specialist
AHME
India
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