Hello,
I have just found out that the Type IV DMF for an excipient used in a drug product my company makes is listed as Inactive on US FDA's website. We were not informed by the DMF holder of the change.
Do Type IV DMFs need to remain continuously active for the lifetime of the drug product? Or is the DMF only really needed during the marketing authorization application?
Thanks,
Maxdisher
I have just found out that the Type IV DMF for an excipient used in a drug product my company makes is listed as Inactive on US FDA's website. We were not informed by the DMF holder of the change.
Do Type IV DMFs need to remain continuously active for the lifetime of the drug product? Or is the DMF only really needed during the marketing authorization application?
Thanks,
Maxdisher