The U.S. Food and Drug Administration (FDA) recently announced the launch of a pilot program involving abbreviated, one-day inspectional assessments at manufacturing and other lower-risk facilities.

Risk management is a major emphasis of FDA’s new compliance program, the Quality Management System Regulation (QMSR), and companies should expect to see big differences in how the agency will conduct ...

The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time ...

Editor's note: This article was updated on 27 April 2026 to correct a typo. COLUMBUS, OH – It isn’t always clear when to choose to verify or validate manufacturing processes. But expert an from the US ...

More than a year after the COVID-19 pandemic forced the US Food and Drug Administration (FDA) to halt most on-site inspections, the agency on Wednesday issued guidance detailing its approach to remote ...