In a 2008 final rule, the FDA said a CBE supplemental NDA should be used to amend the labeling of an approved drug, medical device or biologic product "only to reflect newly acquired information."

The rule also explained that there must be "reasonable evidence of a causal association" before a CBE supplement "may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction." (Also see "Pre-emption Rule Delays Safety-related Label Changes, Waxman Charges" - Pink Sheet, 3 November, 2008.)

CBE label warning changes can be made without prior FDA approval, but the rule requires simultaneous submission of CBE changes to the agency, which has ultimate authority to approve or reject a change.

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