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​Hi David, The API manufacturer is obligated to notify you of the changes (see 21 CFR 314.420 (c)). While they don't have to provide all the details of the change, they should provide sufficient information to allow you to properly assess the impact on the Drug Product and drug product filing. If ...

​Thank you all for the additional information. As previously mentioned, the eDRLS office confirmed that there is no requirement for API intermediates manufacturers to register. I personally have a hard time understanding this, especially because of the "broad" definition of manufacture as mentioned by ...

​Thank you all! I was recently at the AAM conference and was able to discuss with a few people from industry but also with some people from the FDA; the different FDA representatives I spoke to confirmed that this is a "gray" area for API intermediates manufacturers, they should have an FEI number but ...

​Good morning everyone, Do you know of any requirements/regulations that state that Drug Substance Intermediate Manufacturers need to register their establishment with the FDA? The manufacturer is located outside of the US and we have recently received a question as part of a CRL asking for the manufacturer's ...

​Yes it is acceptable to file the type II DMF with 3 month stability data. For the DMF to be considered complete (assuming it's for a generic application), the requirement is to submit the release data and one additional time point for at least one lot (refer to FDA's stability guidance).  I also noticed ...