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From GlobalCompliancePanel
FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel
...ls prior to FDA approval (through changes being effected (CBE) supplements) to ensure consumers are immediately made aware of newly discovered risks.
The labeling regulations, which became effective in late September 2008, clarify that a manufacturer can make unilateral pre-FDA approved labeling changes "only to reflect newly acquired information" when there is "reasonable evidence of a
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