FDA-Approved Labeling: Is Enough Enough?
FDA Law Blog
AUGUST 21, 2023
FDA did, however, try to identify safety issues through the medical literature and (after 2007 when mandatory safety reporting for OTC human drug products marketed without an approved application became effective) through the adverse event reporting system. Just like it was over a decade ago in Pliva v. Take, for example, sunscreens.
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