The “Case for Quality Initiative” is a strategic priority for the US Food and Drug Administration. To support this initiative, the agency is working to implement policies that go beyond compliance with regulations and provide an enhanced focus on the manufacturing quality.
To learn more about this strategic shift at FDA, I spoke with Steve Silverman, Director of the Office of Compliance at the FDA’s Center for Devices and Radiological Health.
We are publishing the interview in a series of articles covering our discussion on the Case for Quality Initiative. Continue reading