Federal Register Final rule: FDA is amending its regulations regarding changes to an approved NDA, BLA, or PMA so that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents. To view this final rule, click here.