FDA Posts PDUFA Meeting Minutes
FDA posted last week the minutes to January 2011 meetings about renewing the Prescription Drug User Fee Act. Industry and regulators discussed cost and inflation measurements as well as small-business waivers. Read the full minutes of industry’s comments here: Jan. 25, 2011 and Jan. 20, 2011.
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.