FDA Provides COVID-19 Resources
The agency has added a COVID-19 innovation resource page and an education resources page to its website.
To provide the public with information regarding COVID-19, FDA has created two web pages on its website: "Innovation to Respond to COVID-19" and "Educational Resources". Innovation to Respond to COVID-19 lists FDA’s innovative approaches to respond to COVID-19. It provides updates to connect manufacturers and healthcare entities, analysis of real-world data, the Coronavirus Treatment Acceleration Program, and guidance documents that promote innovation. Educational Resources provides links to COVID-19-related resources that help explain FDA’s work, including videos, a social media kit, consumer articles, and more.
Source: FDA
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.
