In a bid to better deploy its boots-on-the-ground resources, the FDA is pulling back the curtain on a new pilot program, under which the regulator is leveraging “one-day inspectional assessments” to ...

DLA Piper's Vernessa Pollard (left) and FDA Marty Makary (right) spoke at the FDLI Annual Conference on Wednesday. Marty Makary, the Commissioner of the US Food and Drug Administration (FDA), ...

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...

As of late April 2026, the FDA has completed approximately 46 one-day assessments. Most assessments successfully confirmed compliance, resulting in No Action Indicated (NAI) outcomes. The pilot has ...

In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA is still lagging woefully behind and is unable to approach its pre-COVID ...

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 ...

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...

As COVID-19 swept across the globe in early 2020, the Food and Drug Administration (FDA) pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical ...

The FDA is considering reducing its routine food safety inspections and shifting more responsibility to state agencies. However, critics are concerned that this action could undermine oversight and ...

The US Food and Drug Administration (FDA) has issued warning letters to several drug manufacturers and compounders for ...