Regulatory Roundup: FDA Sets Limits for Acetaminophen in Prescription Combination Products
FDA Sets Limits for Acetaminophen in Prescription Combination Products
FDA is asking manufacturers of prescription combination products that contain acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule, according to an agency release dated Jan. 13, 2011. Because of continued reports of liver injury, FDA also is requiring manufacturers to update labels of all prescription combination acetaminophen products with black boxes to warn of the potential risk for severe liver injury. The elimination of higher-dose prescription combination acetaminophen products will be phased in over three years.
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.
