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Posted On: 07/10/2020 10:37:09 AM
Post# of 148899
Comparability study done of the drug ?? Why not ???
Manufacturing facility been inspected or need to be ?? When was Samsung last inspected by FDA
Do these timelines matter to complete the BLA and get a pdufa date .
Don’t ask questions if you don’t already know the answers .
Manufacturing facility been inspected or need to be ?? When was Samsung last inspected by FDA
Do these timelines matter to complete the BLA and get a pdufa date .
Don’t ask questions if you don’t already know the answers .
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