> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Value of Risk-Based Quality Management
- URL: https://www.fdaweb.com/value-of-risk-based-quality-management/
- Published: 2019-07-18T12:00:00.000Z
- Updated: 2026-09-15T01:38:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144559

Through a risk-based quality management system, FDA can receive data that are reliable, interpretable, and traceable, and thus may be able to act on a drug application before the user fee deadline. And acting on an application sooner can result in less expense for the sponsor. That’s the reason FDA is promoting a risk-based quality management system, according to CDER Office of Scientific Investigations director **David Burrow**. Burrow spoke at a 7/17 FDA/Duke Margolis Center for Health Policy [program](https://healthpolicy.duke.edu/events/improving-implementation-risk-based-monitoring-approaches-clinical-investigations?ref=fdaweb.com) (video link) on “Improving the Implementation of Risk-Based Monitoring Approaches of Clinical Investigations.”

He stressed that the agency was looking at a risk-based quality system rather than solely risk-based monitoring. He defined the system elements as risk assessment, leading to a well-designed and articulated protocol and risk plan, that then leads to a risk-based monitoring plan.

Monitoring activities can be on-site, centralized, and remote, Burrow said, and risk-based monitoring uses all three in a risk-based manner.

CDER Office of Medical Policy director **Jacqueline Corrigan-Curay** referenced two FDA guidances on risk-based monitoring and said the agency is currently reviewing comments received on the guidances. The point of the effort, she said, is to be able to improve clinical trial design and the integrity of trials and their results.

Duke-Margolis deputy director **Greg Daniel** told attendees that the use of risk-based monitoring is growing, but still has not been widely implemented.