The U.S. Food and Drug Administration (FDA) recently announced a pilot program for "One-Day Inspectional Assessments," a new ...

Stakeholders are taking issue with the US Food and Drug Administration’s (FDA) draft guidance on conducting bioresearch monitoring (BIMO) inspections. They are particularly concerned about protecting ...

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.