Modernizing FDA's Ingredient System

Executive Summary

FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.

The National Center for Advancing Translational Sciences (NCATS) is the newest of 27 Institutes and Centers (ICs) at the National Institutes of Health (NIH). This Center was established in December 2011 to transform the translational science process so that new treatments and cures for disease can be delivered to patients faster.

It is a daunting challenge to track and organize all of the ingredient information that FDA is responsible for, including chemicals, polymers, proteins, and botanicals, because the definitions for these ingredients are so complex. Without such a system, ingredient data related to drug safety, drug labeling, and drug recalls is left segmented and unstandardized, and may be called by many different names using different definitions.

The FDA has articulated its strategy for handling these ingredients based on fundamental science rather than naming conventions. To implement this strategy, FDA approached NCATS about repurposing software that existed at NCATS to support FDA’s needs.

Developing the technical implementation required to meet FDA’s standards was challenging, but navigating the regulatory landscape to deploy the application proved to be equally daunting.  At the start of the HHS Ignite Accelerator process this team had prototype software, and FDA colleagues who were eager to use it, but no simple mechanism to let them. The increased visibility and support of the Accelerator led to a full working software deployment on the FDA servers.

A project supported by the: HHS Ignite Accelerator

Team Members

Noel Southall (Project Lead), NIH
Lawrence Callahan, FDA
Dac-Trung Nguyen, NIH
Tyler Peryea, NIH
Frank Switzer, FDA
Timothy Sheils, NIH

Milestones

December 2013: Project selected into the HHS Ignite Accelerator
January 2014: Time in the Accelerator began
April 2014: Time in the Accelerator ended

Project Sponsor

Ajit Jadhav, Director of Probe Development, Division of Pre-Clinical Innovation, National Center for Advancing Translational Sciences, NIH