Regulatory Roundup: FDA and Georgetown University Form Innovation Partnership
FDA and Georgetown University Form Innovation Partnership
FDA and Georgetown University Medical Center have entered a partnership to stimulate innovation in regulatory science, ethics, education, and training, according to a Feb. 24, 2011, agency press announcement. Joint activities will include: research and public-health activities in areas such as novel technologies, public health preparedness, ethics, and bioinformatics; mentorship of doctoral and postdoctoral students in collaborative research relevant to FDA’s mission; scientific staff exchanges and professional-development opportunities, including selected FDA staff serving as adjunct faculty in teaching and clinical activities at Georgetown and selected Georgetown staff participating in research and other activities with FDA; and shared access to and development of important training and continuing education activities.
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.
