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FDA Introduces Data Modernization Action Plan

Posted on March 29th, 2021 by in Pharma R&D

One of the frustrations of our Big Data era is that, despite the existence of an ever-growing wealth of valuable data, this data is often stuck in different silos. This lack of accessibility makes it hard to get the most out of data that has the potential to be extremely useful.

The United States really wrestled with this issue when it came to dealing with health data during the early part of the Covid crisis. There were myriad difficulties with finding, capturing and sharing vital data at a time when we were still learning so much about the disease as the pandemic began raging—and those challenges pointed to a larger problem with the country’s ability to collect public health data.

In the wake of those problems comes an interesting announcement from the U.S. Food and Drug Administration (FDA) about its Data Modernization Action Plan, an encouraging sign that some government agencies are working to improve their data management. The new plan, which comes on the heels of an agency effort to update its technical infrastructure, will optimize and update how the FDA uses its trove of health and safety data.

As the FDA outlines here, the Data Modernization Action Plan has three key components:

*Identify and execute high value driver projects for individual centers and for the Agency

*Develop consistent and repeatable data practices across the Agency

*Create and sustain a strong talent network combining internal strengths with key external partnerships

The agency will be pursuing a number of strategies, from the adoption of new processes and technologies to the development of partnerships across sectors, in order to better function in our modern digital era. There is much to be done in terms of digitization, automation, increasing interoperability, establishing good data practices and much more.

What this will hopefully mean for the pharmaceutical industry down the road is an acceleration in regulatory processes and enhanced post-market surveillance, as well as the helpful involvement of the FDA in more research projects like the real world data-based COVID-19 Evidence Accelerator. We look forward to seeing how drug makers and patients alike benefit from a more data-savvy FDA.

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