ePT--the Electronic Newsletter of Pharmaceutical Technology
FDA has finalized a regulation regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval applicatin (PMA).
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.
A Novel, Enhanced, and Sustainable Approach to Audit Trail Review
July 4th 2025Eli Lilly and Company developed an innovative and sustainable approach to audit trail review (ATR) aimed at reducing the ATR burden while adhering to regulatory expectations and data integrity (DI) principles. The process has transformed employees' understanding of ATR and complemented the DI by design approach, leading to better system designs that meet expected controls and reduce non-value-added data reviews.