FDA Finalizes Labeling Changes Rule

Rockville, MD (Aug. 22)-FDA has finalized a regulation regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). The regulation clarifies a January 2008 FDA proposal indicating when manufacturers may submit a changes being effective (CBE) supplement to amend the labeling for an approved product that would “reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction.”

The final amended CBE regulation further clarifies the definition of “newly acquired information” to be “data, whether derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data” must be of a “different type or greater severity or frequency than previously included in submissions to FDA.”

The January 2008 proposal suggested the “newly acquired information” referred only to data derived from reports of adverse events.

The final regulation will take effect September 22, 2008.

A complete description of the proposed change was published in the Federal Register.