What is a CBE 30?

What is a CBE 30? CBE 30 means a regulatory submission to the FDA at least thirty days prior to distribution of Product indicating changes being effected to the NDA 16-151 as defined in 21 CFR 314. 70(c). What is CBE filing? A filing with the FDA to gain approval of a moderate change, i.e., … Continue reading What is a CBE 30?