FDA-Approved Labeling: Is Enough Enough?
FDA Law Blog
AUGUST 21, 2023
Recall that the funds provided under the Prescription Drug User Fee Acts (PDUFA) are not available to support the agency’s efforts related to monograph drugs.) This is because the presumption that manufacturers can unilaterally make substantive changes to the labeling of an OTC Monograph drug product is false.
40 
Let's personalize your content