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# FDA Lessons for Managing Data Better
- URL: https://www.fdaweb.com/fda-lessons-for-managing-data-better/
- Published: 2020-06-25T12:00:00.000Z
- Updated: 2026-09-14T16:19:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147099

Over the last seven years, FDA has been working to get a handle on its vast data resources to achieve a 360-degree view of the drug development lifecycle. How the agency approached the challenge was recently discussed by CDER Office of Strategic Programs supervisor and computer scientist **Shanthi Vigneshwaran** in a SiliconANGLE CUBE video [conversation](https://siliconangle.com/2020/06/25/fda-gets-360-degree-view-drug-development-life-cycle-eliminating-data-silos-cubeconversations/?ref=fdaweb.com).

Vigneshwaran said the agency approached the large task by breaking it into manageable pieces.

“We were like, let’s take a step back and say ‘Which is the domain … that will give us the most return on investment? Which will make people actually look at it and say ‘Hey, this thing makes sense?” she said.

FDA obtained assistance from Informatica, which recently gave the agency its Intelligent Disruptor of the Year award, to automate a lot of data-quality work through bots and develop major efficiency gains.

“It used to take us three days to process submissions,” Vigneshwaran said. “Now it takes us less than 24 hours to do it.” The agency also now can use data to predict events such as drug shortages and hurricanes that can affect operations.

Vigneshwaran advised other organizations pursuing data transformation to approach it in manageable increments and commit to it for the long haul. “It’s not ‘within one year you’re going to accomplish it,’” she said. “We have to be very patient and it’s a long road. If you make mistakes, you will have to go back and reassess.”